The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Pristina Serena Bright.
| Device ID | K193334 |
| 510k Number | K193334 |
| Device Name: | Pristina Serena Bright |
| 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 | 2019-12-02 |
| Decision Date | 2020-05-15 |