US
Senographe Pristina 3D
🇺🇸GE Healthcare · Digital Breast Tomosynthesis
What it does
Supports the imaging workflow around multi-modality studies — routing, scheduling, or image management — rather than interpreting the images.
Who it's for
Imaging departments and informatics teams managing study flow.
Reported performance
No sensitivity / specificity / AUC was disclosed in the available summary. Many summaries report no standalone metrics — we note that honestly rather than imply a number.
Performance numbers are manufacturer-reported and often single-site; treat them as a starting point, not an independent benchmark.
FDA
PathwayPMA
Submission #P130020/S005
Product codeOTE
Decision dateNov 21, 2025
PanelRadiology
FDA recordaccessdata
EU (CE)
Statusunknown
Risk class—
Notified body—
EMDN code—
Basic UDI-DI—
AI Act class—
EU coverage is filling out through 2026; absence here doesn't mean a device isn't CE-marked.
Vendor
Cite this page
RadPigeon. "Senographe Pristina 3D (GE Healthcare)." AI Devices registry. https://radpigeon.news/ai/device/senographe-pristina-3d
Last updated Jun 29, 2026. Information only — not clinical advice. Summaries are RadPigeon's own wording.
