# K190954: Fundus Camera

- Pathway: 510(k) (Traditional)
- Applicant: Chongqing Bio Newvision Medical Equipment, Ltd.
- Decided: Jan 22, 2020 after 286 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: 8 generations back to K941234 (1995). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122572: Icam Fundus Camera, Optovue, Inc. (2013) Summary page 5.
- K101935: Centervue Digital Retinography System, Centervue S.P.A. (2010) Summary page 5.

## Indications for use
The Fundus Camera RetiCam 3100 is intended to capture digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.

Source page: https://510kreport.com/device/K190954
Methodology: https://510kreport.com/methodology