The following data is part of a premarket notification filed by Intelligent Retinal Imaging Systems, Llc with the FDA for Iris Intelligent Retinal Imaging System.
| Device ID | K141922 |
| 510k Number | K141922 |
| Device Name: | IRIS INTELLIGENT RETINAL IMAGING SYSTEM |
| Classification | System, Image Management, Ophthalmic |
| Applicant | INTELLIGENT RETINAL IMAGING SYSTEMS, LLC 300 BRICKSTONE SQUARE Andover, MA 01810 |
| Contact | Ryan Bouchard |
| Correspondent | Ryan Bouchard INTELLIGENT RETINAL IMAGING SYSTEMS, LLC 300 BRICKSTONE SQUARE Andover, MA 01810 |
| Product Code | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-16 |
| Decision Date | 2015-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001130508 | K141922 | 000 |