The following data is part of a premarket notification filed by Ophthalmic Imaging Systems with the FDA for Ois Eyescan Portable Modular Imaging System, Model Ois Eyescan.
| Device ID | K092374 |
| 510k Number | K092374 |
| Device Name: | OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | OPHTHALMIC IMAGING SYSTEMS 221 LATHROP WAY, SUITE I Sacramento, CA 95815 |
| Contact | Andrea Ambrose |
| Correspondent | Andrea Ambrose OPHTHALMIC IMAGING SYSTEMS 221 LATHROP WAY, SUITE I Sacramento, CA 95815 |
| Product Code | HKI |
| Subsequent Product Code | HJO |
| Subsequent Product Code | NFG |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-05 |
| Decision Date | 2009-11-17 |
| Summary: | summary |