The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Sample Imaging For Senographe Pristina.
| Device ID | K190809 |
| 510k Number | K190809 |
| Device Name: | Sample Imaging For Senographe Pristina |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | GE Healthcare 283 Rue De La Miniere Buc, FR 78530 |
| Contact | Nicole Landreville |
| Correspondent | Nicole Landreville 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 | 2019-03-29 |
| Decision Date | 2019-07-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682143486 | K190809 | 000 |