The following data is part of a premarket notification filed by Ophthalmic Imaging Systems with the FDA for Ois Symphony Image Managment System.
| Device ID | K110006 |
| 510k Number | K110006 |
| Device Name: | OIS SYMPHONY IMAGE MANAGMENT SYSTEM |
| Classification | System, Image Management, Ophthalmic |
| 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 | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-03 |
| Decision Date | 2011-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842000100584 | K110006 | 000 |
| 00842000100553 | K110006 | 000 |
| 00842000100317 | K110006 | 000 |
| 00842000100096 | K110006 | 000 |