The following data is part of a premarket notification filed by Ge Medical Systems Scs with the FDA for Senographe Essential, Premium View I (pvi).
| Device ID | K131885 |
| 510k Number | K131885 |
| Device Name: | SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI) |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | GE MEDICAL SYSTEMS SCS 283 RUE DE LA MINIERE Buc, FR 78530 |
| Contact | Mounir Zaouali |
| Correspondent | Mounir Zaouali GE MEDICAL SYSTEMS SCS 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 | 2013-06-25 |
| Decision Date | 2013-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682123242 | K131885 | 000 |