# K062295: Iri Integrated Retinal Imager

- Pathway: 510(k) (Traditional)
- Applicant: Medivision Medical Imaging, Ltd.
- Decided: Oct 20, 2006 after 74 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K941234 (1995). 9 ancestors in all.
63 later devices descend from it; 3 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041367: Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera, Topcon Corp. (2004) Summary page 2.
- K021787: Visucam, Carl Zeiss Ophthalmic Systems, Inc. (2002) Summary page 2.
- K041546: Digital Fundus Camera, Model CF-60DSI, Canon, Inc. (2004) Summary page 2.

## Most influential descendants
- K101223: Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FA (2010), 41 descendants of its own
- K111157: CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES (2012), 24 descendants of its own
- K092374: Ois Eyescan Portable Modular Imaging System, Model Ois Eyescan (2009), 22 descendants of its own
- K101935: Centervue Digital Retinography System (2010), 21 descendants of its own
- K121993: Spectralis Hra + Oct and Variants, Spectralis FA+ Oct, Spectralis Icga +Oct, Spectralis Oct Blue Peak, Spectralis Oct (2012), 15 descendants of its own

## Indications for use
The IRI Integrated Retinal Imager System is a monocular retinal imager designed for routine use. The imager is suitable for documentation of findings in a clinical setting.

Source page: https://510kreport.com/device/K062295
Methodology: https://510kreport.com/methodology