# K210197: NFC-600 Automated Portable Retinal Camera

- Pathway: 510(k) (Special)
- Applicant: Crystalvue Medical Corporation
- Decided: Apr 13, 2021 after 78 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: 9 generations back to K941234 (1995). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182199: NFC-700 non-mydriatic auto fundus camera, Crystalvue Medical Corporation (2019) Summary page 7.

## Indications for use
NFC-600 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. NFC-600 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.

Source page: https://510kreport.com/device/K210197
Methodology: https://510kreport.com/methodology