Radiology
Senographe Pristina 3D
GE Healthcare
FDA-cleared AI medical device
To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.
FDA Submission Metadata
- Submission number
- P130020/S005
- Decision date
- November 2025
- FDA panel
- Radiology
- Product code
- OTE
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.