IRIS INTELLIGENT RETINAL IMAGING SYSTEM is an AI-enabled medical device from INTELLIGENT RETINAL IMAGING SYSTEMS, LLC that the U.S. FDA cleared through 510(k) K141922 on February 27, 2015. Its lead review panel is Radiology and its primary product code is NFJ (System, Image Management, Ophthalmic).
See also top radiology AI devices.
Key facts
| Submission number | K141922 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | INTELLIGENT RETINAL IMAGING SYSTEMS, LLC |
| Lead review panel | Radiology |
| Primary product code | NFJ — System, Image Management, Ophthalmic |
| Applicant (openFDA) | Intelligent Retinal Imaging Systems, LLC |
| Applicant location | Andover, MA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 892.2050 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. IRIS INTELLIGENT RETINAL IMAGING SYSTEM went through this pathway (K141922).
openFDA lists it as a Class 2 device under 21 CFR 892.2050. Class II devices are moderate risk and are subject to general and special controls.
Product code NFJ covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. INTELLIGENT RETINAL IMAGING SYSTEMS, LLC has 1 AI-enabled device on the list, and the Radiology panel accounts for 1,230 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.