Senographe Pristina
Full Field Digital, System, X-ray, Mammographic
GE Healthcare
The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Senographe Pristina.
Pre-market Notification Details
| Device ID | K211725 |
| 510k Number | K211725 |
| Device Name: | Senographe Pristina |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | GE Healthcare 283 Rue De La Miniere Buc, FR 78530 |
| Contact | Barthelemy Arman |
| Correspondent | Barthelemy Arman GE Healthcare 283 Rue De La Miniere Buc, FR 78530 |
| Product Code | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-04 |
| Decision Date | 2021-08-06 |
Trademark Results [Senographe Pristina]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SENOGRAPHE PRISTINA 86652853 5261610 Live/Registered |
General Electric Company 2015-06-05 |
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