VersaViewer
GE Medical Systems SCSVersaViewer is a medical image management and processing system software developed by GE Medical Systems SCS. It supports 2D, 3D, and 4D medical images from multiple modalities and provides customizable layouts for multimodality review. It offers measurement, annotation, segmentation tools, and advanced visualization options to assist trained healthcare professionals in diagnostic workflows. The software includes an optional One View feature for automated multi-organ segmentation using deep learning, enhancing radiologists' efficiency in interpreting spectral CT exams. It is intended to assist physicians in diagnosis, though physicians retain final decision-making responsibility.
Intended Use
VersaViewer is a medical diagnosis software designed to process 2D, 3D and 4D medical images series, providing radiologists and clinicians with a display framework and tools to ease multimodality imaging review and analysis.
Technology
VersaViewer reconstructs and displays 2D, 3D, and 4D medical images from multiple modalities, provides adaptive layouts, basic and advanced image processing tools including multi-oblique views, and includes an optional One View feature with AI-based deep learning segmentation of multiple organs. It outputs images and findings with DICOM support, streamlining radiological workflows.
Performance
VersaViewer underwent design control testing per GE Healthcare's quality system including verification, validation, software lifecycle assessment, and safety testing. Bench testing was performed for the deep learning segmentation algorithm using a representative retrospective CT exam database, meeting acceptance criteria. Overall, testing confirmed substantial equivalence with predicate devices with no new safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/26/2024
4 months - 2
FDA Approval
4/21/2025
Other devices from GE Medical Systems SCS
- CardIQ Suite2025 • 510K
- 3DXR2025 • 510K
- CardIQ Suite2024 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.