# K202097: Fundus Camera

- Pathway: 510(k) (Traditional)
- Applicant: Huvitz Co., Ltd.
- Decided: Feb 2, 2021 after 188 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113451: Non-Mydriatic Auto Fundus Camera Afc-330 with Image Filing Software NA Vis-EX, Nidek Technologies Srl (2012) Summary page 4.

## Indications for use
HFC-1 fundus camera is intended to capture digital images for the anterior and retina segment of the eye without the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health.

Source page: https://510kreport.com/device/K202097
Methodology: https://510kreport.com/methodology