# K250683: Resolve Fundus Camera

- Pathway: 510(k) (Traditional)
- Applicant: Optain Health, Inc.
- Decided: Apr 30, 2025 after 55 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). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180306: Nexy, Next Sight Srl (2018) Summary page 5.

## Indications for use
The Resolve Fundus Camera is an automatic eye-fundus camera intended for taking digital images of a human retina with or 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/K250683
Methodology: https://510kreport.com/methodology