Pristina Serena
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 Pristina Serena.
Pre-market Notification Details
| Device ID | K173576 |
| 510k Number | K173576 |
| Device Name: | Pristina Serena |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | GE Healthcare 283 Rue De La Miniere Buc, FR 78530 |
| Contact | Gregory Pessato |
| Correspondent | Gregory Pessato 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 | 2017-11-20 |
| Decision Date | 2018-05-14 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682143424 | K173576 | 000 |
| 00840682139397 | K173576 | 000 |
| 00840682139229 | K173576 | 000 |
| 00195278347596 | K173576 | 000 |
Trademark Results [Pristina Serena]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRISTINA SERENA 87694484 not registered Live/Pending |
General Electric Company 2017-11-22 |
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