# K141922: Iris Intelligent Retinal Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Retinal Imaging Systems, LLC
- Decided: Feb 27, 2015 after 226 days
- Product code: NFJ (System, Image Management, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K896095 (1990). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113696: Optos Advance, Optos Plc. (2012) Summary page 4.
- K122938: Forum Forum Archive Forum Archive & Viewer Forum Assist Match, Carl Zeiss Meditec, AG (2012) Summary page 4.

## Indications for use
The IRIS Intelligent Retinal Imaging Systems is a comprehensive web-based software system application intended for use in storing, managing, and displaying patient data, diagnostic data and images from computerized diagnostic instruments or systems. Original and color amplified images can be viewed by trained healthcare professionals.

Source page: https://510kreport.com/device/K141922
Methodology: https://510kreport.com/methodology