# K250770: Optina-4C (MHRC-C1N)

- Pathway: 510(k) (Traditional)
- Applicant: Optina Diagnostics, Inc.
- Decided: Sep 4, 2025 after 175 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). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231230: Optina-4C (MHRC-C1N), Optina Diagnostics, Inc. (2023) Summary page 5.

## Indications for use
Optina-4C TM is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying, storing, and transferring images of the retina. The Optina-4C is indicated for the viewing of the posterior segment of the eye at multiple wavelengths (colors) under mydriatic conditions. Images are intended to aid clinicians in the detection, diagnosis, and management of ocular health and disease.

Source page: https://510kreport.com/device/K250770
Methodology: https://510kreport.com/methodology