A 3D-printed Personalized, Combined, Modular Pedicle Subtraction Osteotomy Guide Plate System: An Experimental Study.

To explore the application value of 3D printing technology in preoperative surgery plan and intraoperative auxiliary operation for adult kyphoscoliosis deformity. The clinical data of 12 adult patients with kyphoscoliosis deformity treated from September 2017 to January 2019 were retrospectively analyzed. There were 3 males and 9 females, aged from 21 to 63 years old with an average of (47.67±13.32) years old. Among them, 4 cases were congenital kyphoscoliosis, 2 cases were old tuberculosis thoracolumbar kyphosis ; 2 cases were idiopathic kyphoscoliosis, 4 cases were degenerative kyphoscoliosis. The CT scan data of the patient's spine was imported into Mimics17.0 software to establish the three dimensional model of the spine, and the spine model was produced by 3D printer. Using the spine model simulated operation, preoperative surgery program planning and formulated a precise surgery, and further analysed postoperative imaging parameters improvement. All the patients were followed up for more than 1 year. Before and after operation and at the last follow-up, the scoliosis Cobb angle, maximum kyphosis Cobb angle, and coronal plane balance (distance between C 7 plumbline and center sacral vertical line, C7PL-CSVL), sagittal plane balance (sagittal vertical axis, SVA), pelvic parameters and other related imaging parameters were measured to further evaluate its orthopedic effect. Twelve patients with spine deformity were treated with different osteotomy and internal fixation fusion methods under the guidance of a 1∶1 spine model (pedicle screw placement of 4 patients with severe deformity were assisted by pedicle screw guide plates), nail placement and osteotomy have good effects, no major tissue damage such as blood vessels, nerves and spinal cord during and after surgery, no complications such as cerebrospinal fluid leakage and infection. Preoperative Cobb angle of scoliosis was (56.5±22.5) °, Cobb angle of kyphosis was (65.2±19.5) °, C7 PL-CSVL was (45.8±16.9) mm, SVA was (48.7±25.4) mm. Postoperative at 4 weeks, Cobb angle of scoliosis was (20.8±11.5) °, and Cobb angle of kyphosis was (22.0±6.6) °, with correction rates of (65.1±9.7)% and (64.6± 10.6)%, respectively ; C7 PL-CSVL was (22.3±8.9) mm, and SVA was (23.3±13.1) mm, all of which were significantly improved compared with preoperative results. The mean follow-up time was (18.5±7.9) months in 12 patients. At the last follow-up, the Cobb angles of scoliosis and kyphosis were (22.2±10.8) ° and (23.6±7.7) °, respectively, C7 PL-CSVL was (23.5±10.8) mm, and SVA was (24.7±12.5) mm. The results were statistically significant compared preoperative (P<0.05). There was no significant difference at the postoperative at 4 weeks and the last follow-up (P>0.05). The 3D print model can visually and clearly show the vertebral morphology and structure of adult kyphoscolisis and its spatial relationship with the adjacent vertebrae, blood vessels, and nerves, which provides a good and intuitive stereoscopic anatomical structure observation for the individualization of the surgical plan. Pre-simulation of operations to determine the internal fixation, fusion segment and osteotomy orthopedic way, may to provide a reference for actual clinical surgery, and can improve the accuracy and safety of surgery.

Radiomics Prediction of Radiation Treatment Outcomes in Oropharyngeal Cancer: A Clinical and Image Repository in Concert with the Cancer Imaging Archive (TCIA)

Forensic facial approximation was applied to a 5000-year-old female skull from a shell midden in Guar Kepah, Malaysia. The skull was scanned using a computed tomography (CT) scanner in the Radiology Department of the Hospital Universiti Sains Malaysia using a Light Speed Plus scanner with a 1 mm section thickness in spiral mode and a 512 × 512 matrix. The resulting images were stored in Digital Imaging and Communications in Medicine (DICOM) format. A three-dimensional (3D) model of the skull was obtained from the CT scan data using Blender’s 3D modelling and animation software. After the skull was reconstructed, it was placed on the Frankfurt plane, and soft tissue thickness markers were placed based on 34 Malay CT scan data of the nose and lips. The technique based on facial approximation by data extracted from facial measurements of living individuals showed greater anatomical coherence when combined with anatomical deformation. The facial approximation in this study will pave the way towards understanding face prediction based on skull structures, soft tissue prediction rules, and soft tissue thickness descriptors.

4 - Digital Imaging and Communications in Medicine

Over the past 15 years Digital Imaging and Communications in Medicine (DICOM) has established itself as the international standard for medical image communication. Most medical imaging equipment uses DICOM network and media services to export image data, thus making this standard highly relevant for medical image processing. The first section of this chapter provides a basic introduction into DICOM with its more than 3,600 pages of technical documentation, followed by a section covering selected advanced topics of special interest for medical image processing. The introductory text familiarizes the reader with the standard’s main concepts such as information objects and DICOM media and network services. The rendering pipeline for image display and the concept of DICOM conformance are also discussed. Specialized DICOM services such as advanced image display services that provide means for storing how an image was viewed (“Softcopy Presentation States”) and how multiple images should be aligned on an output device (“Structured Display” and “Hanging Protocols”) are described. We further describe DICOM’s sophisticated approach (“Structured Reporting”) for storing structured documents such as CAD information, which is then covered in more detail. Finally, the last section provides an insight into a newly developed DICOM service called “Application Hosting”, which introduces a standardized plug-in architecture for image processing, thus permitting users to utilize cross-vendor image processing plug-ins in DICOM applications.

We read with interest the Opinion of Day and colleagues regarding speckle-tracking assessment of fetal myocardial deformation1 and we would like to share a few comments. First, figure 1 suggests that the strain is computed for the entire myocardium, as represented by the dotted lines on the image of the septal and lateral walls of the left ventricle. It is not clear if this approach has been used to compute the individual endocardial strain (inner dotted line), the myocardial strain (middle dotted line) or the epicardial strain (outer dotted line), or a sum of all three. The authors should clarify if their results represent a composite measurement of the endocardial, myocardial and epicardial strain, or each of these portions separately. Second, the authors state that ‘In the absence of an electrocardiogram signal (as in fetal echocardiography), data transfer using the Digital Imaging and Communications in Medicine (DICOM) format standard occurs at a frame rate of 25–30 fps [frames per second]’. While this may be true for earlier studies, current ultrasound technology allows the DICOM frames to be acquired and exported at a frame rate equal to the frequency of image acquisition2. The authors cite our review of speckle tracking of the fetal heart (their reference 54) in which we provide an illustration (figure 1) of frame rates acquired with ultrasound machines used in obstetric assessment, which demonstrates frame rates ranging between 50 and 218 per second. These frames were exported from the ultrasound machine in DICOM format. Thus, DICOM export of image frames used in speckle-tracking analysis is not limited to between 25 and 30 fps, but rather, it is possible to achieve frame rates that are equivalent to those obtained during image acquisition2. Third, in another study from our group cited by Day et al. (their reference 37), we found that left ventricular longitudinal strain did not change as a function of gestational age and the mean left ventricular global strain was –22.93%3. In the same paper, we compared our results with the mean and SD values of left ventricular global strain reported in 14 other studies (table 4) and found that, in all but five of them, the delta Z-score values were within 2 SD of our findings. All of the reported studies were performed on dedicated cardiovascular ultrasound machines, while our study used an offline program that only required DICOM clips for analysis3. Lastly, we have reported a number of cardiac measurements derived from speckle-tracking analysis of the right and left ventricular endocardium that analyze ventricular size, shape and contractility2-13. This analysis, a relatively new adaptation of speckle-tracking assessment, enables the examiner to obtain numerous cardiac measurements from a single endocardial tracing of each ventricle, which takes less than 3 min, and is now commercially available on ultrasound platforms dedicated primarily to fetal evaluation. In conclusion, we appreciate the insights of Day and colleagues regarding the benefits and limitations of speckle-tracking assessment of fetal myocardial deformation, however, our experience to date suggests that speckle tracking of the fetal heart has great potential, it demonstrates adequate frame rates, it is reproducible and easy to obtain, and can provide simultaneous measurements of ventricular size, shape and contractility.

INTRODUCTION Over the years, the number of patients undergoing radiological examinations has increased tremendously, concomitant with the growing concern regarding the long-term risks of cancer arising from ionising radiation exposure. Consequently, more attention has been focused on the levels of radiation doses received by patients. Large-scale dose surveys have been performed to assess the radiation doses from radiological examinations. A survey carried out in the UK in the early 1980s showed that the average doses from similar radiographic examinations could vary by up to seven times between different hospitals and up to 100 times between hospitals and that radiation doses could vary by up to 100 times between patients.[1] In many instances, the doses were higher than what was necessary to produce an image quality sufficient enough to make a diagnosis. Since the findings of these dose surveys were publicised, more emphasis has been placed on the need to optimise imaging conditions to minimise the risk to patients from radiation exposure.[2] The results of these and similar surveys had formed the basis of recommendations for the levels of dose quantities surveyed. These recommendations were referred to in diverse terms such as guidance levels, exposure guides, guideline doses, reference doses, and in 1996, the International Commission on Radiological Protection (ICRP) introduced the term 'diagnostic reference levels (DRLs)' in their recommendations.[3] Since the publication of this document in 1996, many countries have established national DRLs for various imaging modalities. The latest guidance on DRLs from the ICRP was released in 2017.[4] In 1999, the European Commission issued guidance on the establishment of DRLs in its directive on radiation protection, and these recommendations have been updated regularly since then.[5] DRLs are dose levels for typical imaging examinations that are determined from groups of standard sized patients and these imaging examinations are performed on broadly defined types of equipment. Also, DRLs have been recognised to be an effective means to indicate whether, in routine conditions, the dose to a patient in a specified radiological procedure for medical imaging is unusually high or low. Currently, there are no national DRLs for Singapore or recommended DRLs at our institution. Therefore, we conducted an institutional dose study to determine the typical radiation doses and DRLs for selected imaging examinations or procedures performed in our institution. We also compared our typical radiation dose levels and DRLs with those published for similar imaging practices, which serves to provide a broad indication of our institution's relative performance in terms of radiation dose. Importantly, establishing our baseline dose levels and DRLs will also enable benchmarking with other institutions and the worldwide literature, so that dose improvement processes may be implemented where necessary. METHODS The survey on radiation doses from imaging examinations was reviewed and approved by the hospital's Institutional Review Board. The dose data was collected retrospectively from the examination databases of a picture archiving and communication system (PACS). A sample size of about 100 patients (on average) was used for each selected radiographic examination. As the radiation dose for an X-ray examination is dependent on the size of the patient, it is essential to have some criteria to control the patient size if the number of patients in a sample (from which data are collected) is limited. For this dose survey, we achieved this by using dose data from patients with weights restricted to a range of 50–80 kg. The radiographic examinations or procedures selected for the dose survey were: (a) abdomen anteroposterior (AP); (b) ankle two views; (c) chest posteroanterior (PA); (d) chest lateral (lat); (e) cervical spine AP; (f) cervical spine lat; (g) thoracic spine AP; (h) thoracic spine lat; (i) lumbar spine AP; (j) lumbar spine lat; (k) elbow two views; (l) knee two views; (m) pelvis AP; and (n) shoulder AP and lateral scapula view. After each radiographic examination, the X-ray images will be transferred to PACS in the Digital Imaging and Communications in Medicine (DICOM) format. The DICOM medical image consists of two components: a header and the actual image.[6] The header consists of data that describe the image, the critical data being patient information and the dose quantity recorded for radiation exposure. We have chosen to collect dose data from the selected DICOM studies to perform the dose survey. The dose quantity surveyed should be easily available and preferably the one that directly evaluates the radiation that the patient is exposed to during the examination.[4] In our institution, air kerma–area product (PKA) meters are installed in all digital radiography (DR) rooms, and thus, PKA was the dose quantity collected for this survey. An illustration of PKA measurement is presented in Figure 1. This quantity is quoted in units of Gray square centimetre (Gy cm²); it assesses the amount of radiation (measured in Gray) and the area to which it is delivered (measured in square centimetre).Figure 1: Air kerma–area product PKA measurement.RESULTS Based on the 1992 recommendations of the Institute of Physical Sciences in Medicine/National Radiological Protection Board/College of Radiographers, a survey for a radiographic examination in an X-ray facility should generally involve collection of data on the dose quantity for at least 20 patients to achieve sufficient accuracy in the results.[7] In this dose survey, the average sample size for the various examinations was 109. Age of the selected patients ranged from 17 to 94 years. The results of the dose survey and the 75th percentile values of the dose distributions are presented in Table 1. Data from a dose survey could be used to develop institution DRL for a group of examination rooms or imaging facilities. In surveys where several examination rooms or facilities are involved, having the institution DRL value fixed at the 75th percentile of the dose distribution will help us to consider if more attention is required for optimisation of the radiation dose and to identify which X-ray units require this optimisation.Table 1: Median and 75th percentile doses.DISCUSSION In the current study, PKA was the ideal dose quantity collected, especially for radiography and fluoroscopy, as all the X-rays incident on the patient can be assessed by the PKA meter. The assumption is that the X-ray beam to the patient will be collimated aptly. Since both the X-ray beam size and the air kerma will determine the values of PKA, all factors that could influence patient dose during an examination have been considered. In an X-ray system installed with a PKA meter or where PKA is calculated, this dose quantity is easily available. As the PKA values are based on actual radiographic projections, these data from imaging examinations will provide DRL quantities that are closely related to clinical practice. However, we should note that if the X-ray beam passes through the patient table before exposing the patient, the PKA values will be influenced by beam attenuation by the table. Although the PKA values (evaluated by the meter or calculated by the system) reported in the DICOM header are readily available, we should always verify the accuracy of these values before a survey. The values of PKA may be considerably higher than those appearing on the DICOM header unless these values have been verified periodically. The ICRP has recommended that a procedure should be set up to calibrate the PKA meters and verify the accuracy of PKA displayed by the imaging system, before the readings are recorded in the DICOM radiation dose structured report.[4] The report was developed to record and store all information on each irradiation event that are related to the radiation dose received by the patient. For irradiation-based imaging modalities, this information will include the radiation dose from projection X-ray, computed tomography and radiopharmaceutical administration in nuclear medicine. Before this dose survey, we checked the accuracy of the PKA meters in the DR rooms during quality assurance testing of these systems. There are no established national DRLs for imaging examinations in Singapore. Therefore, we compared our results with the DRLs of the UK and Republic of Ireland, and with the most common values of DRLs from the European Union (EU) member states in terms of PKA.[8,9] The most common values of DRLs are published in the European Union document, Radiation Protection No. 180.[10] Compared to these published figures, our median and 75th percentile values from the dose survey were all demonstrably lower. Figure 2 shows the comparison of DRLs (75th percentile values) from the UK, Republic of Ireland, European Union and our dose survey. We also compared the median DRLs from our dose survey with those from the Republic of Ireland [Figure 3].Figure 2: Graph shows outcome of 75th percentile of survey as referenced to published diagnostic reference levels. AP: anteroposterior, DRLs: diagnostic reference levels, EU: European Union, Lat: lateral, PA: posteroanterior, UK: United kingdom, Y: lateral scapulaFigure 3: Graph shows comparison of dose survey median vs. Irish national median. AP: anteroposterior, Lat: lateral, PA: posteroanterior, Y: lateral scapulaThe current UK DRL is based on their 2010 national dose review, where 65% of the observed PKA doses were acquired from the computed radiography (CR) systems and only 32% from the DR (flat panel detector) systems.[11] The remaining 3% came from the systems using film screen (FS). This review also showed that the doses for DR systems were lower compared to the CR systems and the FS systems. The most common values for DRLs from the European Union were released in 2014. Hence, these values were acquired from a mixture of DR, CR and FS systems. Even for the Irish national DRLs that were released in 2021, only 79% of the surveyed facilities used the DR systems, 8% of the facilities used a combination of DR and CR systems and the remaining 13% of the facilities were using the CR systems. Our results, which are based entirely on DR systems, are therefore, lower than these DRLs. Another factor contributing to our lower DRLs is the difference in patient weight. The weight range for these international DRLs was around 70 ± 15 kg compared to our weight range of 50–80 kg. Performing a dose survey required considerable time and effort to manually collect the dose data and determine the typical (median) doses and DRLs for selected imaging examinations. After conducting the dose survey, we realised that a patient radiation dose monitoring system will improve the collection, analysis and reporting of radiation dose data compared to the current manual method. Having a patient radiation dose monitoring system installed in our institution will enable us to collect, monitor and analyse the radiation dose received by to our patients, and to create DRLs for imaging examinations in a largely automated way. With the advantage of more data from the imaging examinations, it will render assessment of radiation doses a lot easier and more accurate. The established dose values will also be more precise. The detailed information provided by dose monitoring software will allow us to optimise the image quality while minimising radiation exposure to the patient. Overall, the radiation doses obtained in this study were lower compared to the published DRLs of other countries around the world. As the imaging procedures are being optimised and improved, and as advances are being made in the imaging technology, the radiation dose received by patients for radiological examinations is projected to drop progressively. Hence, the DRL values should be reviewed regularly.[4] Countries with established DRLs had conducted reviews of radiation doses every 3–5 years, but this interval between the dose surveys will depend on the availability of the required manpower to undertake these surveys, the introduction of new hardware or software for imaging procedures, consistency of the survey results and participation of the imaging facilities in these countries. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.

In the past, many of the medical information produced by hospitals (such as medical records or imagery) have had trouble being transferred from place to place; the main reason for this being the fference in the many formats that are used by each and every brand. With the development of the ages, the need for exchange of medical information has increased. Thus, imagery medical information uses the DICOM (Digital Image and Communication in Medicine) standard. The goal of this study is to establish a reformatting interface using the DICOM file management system to transfer paper-based records into DICOM format. Once in DICOM format, these records can then be sent to the DICOM server so that they may be accessed via the DICOM Viewer cross hospitals. This study also aims to transform text information into DICOM format so that files may be exchanged with other hospitals through DICOM’s secure system so that medical records can be incorporated into hospitals’ image systems to form a congregation of hospital resources.

This study aimed to evaluate 2 advanced methods for presurgical calculation of bilateral alveolar cleft defect volume using 3-dimensional (3D) printing and computer-aided engineering (CAE) software. Twelve patients with bilateral alveolar cleft (4 females, 8 males, age range 8-11 years) were enrolled in the study. All patients underwent preoperative helical computed tomography scans, and the digital imaging and communications in medicine (DICOM) data of the computed tomography images were analyzed using 3D printing and CAE software. The 3D-printed model used a simulated graft, and graft volume was measured by water displacement. The CAE software used a subtractive method to calculate volume. Simulated graft volumes and CAE-software-derived volumes were compared using Pearson's correlation test and paired Student's t-test. The average volume of the simulated bone grafts obtained using 3D-printed models was 1.45 mL, which was lower than the CAE-software-derived mean volume of 1.52 mL. The mean calculation time using the 3D-printed model was 51.5 minutes, which was 32.1 minutes longer than the average 19.4 minutes when using CAE software. Paired Student's t-test revealed no statistically significant difference between the volumes derived from these methods. The results of this study further validated the use of 3D printing and CAE technique in bilateral alveolar defect repair. The CAE software is more cost-effective in presurgical volumetric assessment. Moreover, 3D models overcome limitations of 3D visualizations by providing tactile feedback and superior appreciation of visuospatial relationships among anatomical structures.

A number of clinical specialties routinely use images in treating patients, for example ophthalmology, dentistry, cardiology, endoscopy, and surgery. These images are captured by a variety of commercial digital image acquisition systems. The US Department of Veterans Affairs has been working for several years on advancing the use of the Digital Imaging and Communications in Medicine (DICOM) Standard in these clinical specialties. This is an effort that has involved several facets: (1) working with the vendors to ensure that they satisfy existing DICOM requirements, (2) developing interface software to the VistA hospital information system (HIS), (3) field testing DICOM systems, (4) deploying these DICOM interfaces nation-wide to all VA medical centers, (5) working with the healthcare providers using the system, and (6) participating in the DICOM working groups to improve the standard. The VA is now beginning to develop clinical applications that make use of the DICOM interfaces in the clinical specialties. The first of these will be in ophthalmology to remotely screen patients for diabetic retinopathy.

To investigate the impact of three-dimensional (3D) printed pelvicaliceal system models on residents' understanding of pelvicaliceal system anatomy before percutaneous nephrolithotripsy (PCNL). Patients with unilateral complex renal stones indicating PCNL were selected. Usable data of patients were obtained from CT-scans in Digital Imaging and Communications in Medicine (DICOM) format. Mimics software version 16.0 (Materialise, Belgium) was used for segmentation and extraction of pelvicaliceal systems (PCSs). All DICOM-formatted files were converted to the stereolithography file format. Finally, fused deposition modeling was used to create plasticine 3D models of PCSs. A questionnaire was designed so that residents could assess the 3D models' effects on their understanding of the anatomy of the pelvicaliceal system before PCNL (Fig. 3). Five patients' anatomically accurate models of the human renal collecting system were effectively generated (Figs. 1 and 2). After presentation of the 3D models, residents were 86% and 88% better at determining the number of anterior and posterior calices, respectively, 60% better at understanding stone location, and 64% better at determining optimal entry calix into the collecting system (Fig. 5). Generating kidney models of PCSs using 3D printing technology is feasible, and the models were accepted by residents as aids in surgical planning and understanding of pelvicaliceal system anatomy before PCNL.

Over the last decade, the specification of a standard format for digital (medical) images has received a great deal of attention. The yearly meetings of the ACC (95 and 96) and ESC (95) were used to promote the DICOM (Digital Imaging and Communications in Medicine) format, the result of a joined effort by the ACC, ACR, NEMA and ESC. At the moment, one of the most interesting questions is: how will the introduction of the DICOM standard affect the daily practice in the catheterization laboratory (cath lab) in the near future?

ObjectiveAneurysm volume quantification (AVQ) using the equation of ellipsoid volume is widely used although it is inaccurate. Furthermore, AVQ with 3-dimensional (3D) rendered data has limitations in general use. A novel universal method for AVQ is introduced for any diagnostic modality and application to any shape of aneurysms.MethodsRelevant AVQ studies published from January 1997 to June 2019 were identified to determine common methods of AVQ. The basic idea is to eliminate the normal artery volume from 3D model with the aneurysm. After Digital Imaging and Communications in Medicine (DICOM) data is converted and exported to stereolithography (STL) file format, the 3D STL model is modified to remove the aneurysm and the volume difference between the 3D model with/without the aneurysm is defined as the aneurysm volume. Fifty randomly selected aneurysms from DICOM database were used to validate the different AVQ methods.ResultsWe reviewed and categorized AVQ methods in 121 studies. Approximately 60% used the ellipsoid method, while 24% used the 3D model. For 50 randomly selected aneurysms, volumes were measured using 3D Slicer, RadiAnt, and ellipsoid method. Using 3D Slicer as the reference, the ratios of mean difference to mean volume obtained by RadiAnt and ellipsoid method were -1.21±7.46% and 4.04±30.54%, respectively. The deviations between RadiAnt and 3D Slicer were small despite of aneurysm shapes, but those of ellipsoid method and 3D Slicer were large.ConclusionIn spite of inaccuracy, ellipsoid method is still mostly used. We propose a novel universal method for AVQ that is valid, low cost, and easy to use.

Conventional magnetic resonance imaging (MRI) studies depict disease of the human brain in 2D but the reconstruction of a patient’s brain stricken with multiple sclerosis (MS) in 3D using 2D images has not been attempted. Using 3D reconstruction algorithms, we built a 3D printed patient-specific brain model to scale. It is a first of its kind model that depicts the total white matter lesion (WML) load using T2 FLAIR images in an MS patient. The patient images in Digital Imaging and Communications in Medicine (DICOM) format were imported into Mimics inPrint 2.0 (Materialise NV, Leuven, Belgium) a dedicated medical image processing software for the purposes of image segmentation and 3D modeling. The imported axial images were automatically formatted to display coronal and sagittal slices within the software. The imaging study was then segmented into regions and surface rendered to achieve 3D virtual printable files of the desired structures of interest. Rendering brain tumor(s) in 3D has been attempted with the specific intent of extending the options available to a surgeon but no study to our knowledge has attempted to quantify brain disease in MS that has, for all practical purposes, no surgical options.

In medical devices, nonconformance with Digital Imaging and Communications in Medicine (DICOM) standard is a serious risk. DICOM nonconformance radiology devices could cause undetected image loss, increasing examination time, and costs in health centers and could even result in the wrong patient treatment. However, there is a rich literature on medical standards that identify the best practices for producing safe and effective medical software. However, these standards do not expressly provide tools to deal with all the relevant DICOM compatibility issues in a specific case. This study aims to introduce a systematic software development workflow that complies with medical standards and ensures DICOM conformance of a new or upgraded radiology software project. In this approach, DICOM conformance gets the highest priority, and the whole software project is organized around it. Software requirement analysis, risk evaluation, and test management tasks are arranged systematically to make the final device DICOM conformant. This conceptual framework was developed during the R&D work towards a novel radiography device, and it could be employed as a roadmap in other medical imaging software projects. The proposed methodology controls the DICOM compatibility risk of the final software, and its systematic evaluation complied with medical standards.