The following data is part of a premarket notification filed by Retinai Medical Ag with the FDA for Retinai Discovery.
| Device ID | K211715 |
| 510k Number | K211715 |
| Device Name: | RetinAI Discovery |
| Classification | System, Image Management, Ophthalmic |
| Applicant | RetinAI Medical AG Freiburgstrasse, 3 Bern, CH 3010 |
| Contact | Enisa Dresevic |
| Correspondent | Enisa Dresevic RetinAI Medical AG Freiburgstrasse, 3 Bern, CH 3010 |
| Product Code | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-03 |
| Decision Date | 2022-04-28 |