Senographe Pristina 3D is an AI-enabled medical device from GE Healthcare, listed by FDA (PMA supplement, P130020/S005) with a decision date of 2025-11-21. Review panel: Radiology.
| FDA submission number | P130020/S005 |
|---|---|
| Pathway | PMA supplement |
| Company | GE Healthcare |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-11-21 |
| Product code | OTE |
| Classification | Digital Breast Tomosynthesis |
| Device class | 3 |
| Review time (calendar days) | 214 |
Official FDA database record · FDA AI-enabled device list
More devices from GE Healthcare · All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.