The following data is part of a premarket notification filed by Centervue Spa with the FDA for Centervue Digital Retinography System.
| Device ID | K101935 |
| 510k Number | K101935 |
| Device Name: | CENTERVUE DIGITAL RETINOGRAPHY SYSTEM |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | CENTERVUE SPA PIAZZA ALBANIA 10 Rome, IT 00153 |
| Contact | Roger Gray |
| Correspondent | Roger Gray CENTERVUE SPA PIAZZA ALBANIA 10 Rome, IT 00153 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-12 |
| Decision Date | 2010-10-27 |
| Summary: | summary |