# K122572: Icam Fundus Camera

- Pathway: 510(k) (Traditional)
- Applicant: Optovue, Inc.
- Decided: Jan 11, 2013 after 141 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: 7 generations back to K941234 (1995). 19 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101935: Centervue Digital Retinography System, Centervue S.P.A. (2010) Summary page 1.

## Most influential descendants
- K182199: NFC-700 non-mydriatic auto fundus camera (2019), 3 descendants of its own
- K222166: SOLIX (2022), 1 descendant of its own
- K251848: Pentacam® Cornea OCT (2026), 0 descendants of its own
- K242508: Verily Numetric Retinal Camera (2024), 0 descendants of its own
- K230627: Zilia Ocular FC (ZIL-10002) (2023), 0 descendants of its own

## Indications for use
The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. iCam is indicated for in-vivo viewing of the posterior and external area of the eye and the images are intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health. iCamn provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease

Source page: https://510kreport.com/device/K122572
Methodology: https://510kreport.com/methodology