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aPROMISE X is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging. using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis.

aPROMISE (automated PROstate specific Membrane Antigen Imaging SEgmentation) X is an updated version of previously cleared device, aPROMISE v 1.2.1 (K211655), with a web interface where users can upload body scans of PSMA PET/CT image data in the form of DICOM files, review patient studies and share study assessments within a team. The software platform has two installation configurations: either deployed to a cloud infrastructure or to a local server at a clinical facility. The software platform can communicate via http-protocol as described in part 18 of the DICOM standard. This compatibility enables direct transmission of DICOM data from a PACS to aPROMISE X. Manual upload via aPROMISE X user interface is also supported. The software complies with the Digital Imaging and Communications in Medicine (DICOM) 3 standard. Multiple scans can be uploaded for each patient and the system provides a separate review for each study. The review page display studies in a 4-panel view showing PET, CT, PET/CT fusion and maximum intensity projection (MIP) simultaneously and includes the option to display each view separately. The device is used to review entire patient studies, using image visualization and analysis tools for users to identify and mark regions of interest (ROIs). While reviewing image data, users can mark ROIs by selecting from pre-defined hotspots that are highlighted when hovering with the mouse pointer over the segmented region, or by manual drawing, i.e selecting individual voxels in the image slices to include as hotspots. Selected or drawn hotspots are subject to automatic quantitative analysis. The user can review the results of this quantitative analysis and determine which hotspots should be reported as suspicious lesions. To create a report the signing user is required to confirm quality control, and electronically sign the report preview. Signed reports are saved in the device and can be exported as a JPG or DICOM file.

aPROMISE is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis.

aPROMISE (automated PROstate specific Membrane Antigen Imaging SEgmentation) consists of a cloud-based software platform with a web interface where users can upload body scans of PSMA PET/CT image data in the form of DICOM files, review patient studies and share study assessments within a team. The software complies with the Digital Imaging and Communications in Medicine (DICOM) 3 standard. Multiple scans can be uploaded for each patient and the system provides a separate review for each study. The review page display studies in a 4-panel view showing PET, CT, PET/CT fusion and maximum intensity projection (MIP) simultaneously and includes the option to display each view separately. The device is used to review entire patient studies, using image visualization and analysis tools for users to identify and mark regions of interest (ROIs). While reviewing image data, users can mark ROIs by selecting from pre-defined hotspots that are highlighted when hovering with the mouse pointer over the segmented region, or by manual drawing, i.e selecting individual voxels in the image slices to include as hotspots. Selected or drawn hotspots are subject to automatic quantitative analysis. The user can review the results of this quantitative analysis and determine which hotspots should be reported as suspicious lesions. To create a report the signing user is required to confirm quality control, and electronically sign the report preview. Signed reports are saved in the device and can be exported as a JPG or DICOM file.

aBSI is intended to be used by trained healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images acquired using nuclear medicine (NM) imaging. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including lesion marking and quantitative analysis.

The aBSI is a software-only medical device that provides a fully quantitative assessment of a patient's skeletal disease on a bone scan, as the fraction of the total skeleton weight. The user of this product is typically a health-care professional using the software to view the patient images and analysis results.

EXINI is intended to be used by trained healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear imaging (NM) and computed tomography (CT). The software provides general Picture Archiving and Communications System (PACS) tools and a clinical application for oncology including lesion marking and analysis.

The EXINI software provides trained health-care professionals and researchers with a software tool set for acceptance, transfer, storage, image display, manipulation and quantification of digital medical images. The software is intended to be used with images acquired using nuclear imaging (NM) and computed tomography (CT) modalities. The software provides general Picture Archiving and Communications System (PACS) tools and a clinical application for markup and analysis of bone lesions in bone scans. The software complies with the Digital Imaging and Communications in Medicine (DICOM 3) standard. The software runs on a standard PC with Microsoft Windows operating system.