# K231230: Optina-4C (MHRC-C1N)

- Pathway: 510(k) (Special)
- Applicant: Optina Diagnostics, Inc.
- Decided: Dec 5, 2023 after 221 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: 7 generations back to K941234 (1995). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200254: Mydriatic Hyperspectral Retinal Camera (MHRC-C1), Optina Diagnostics (2020) Summary page 4.

## Most influential descendants
- K250770: Optina-4C (MHRC-C1N) (2025), 0 descendants of its own

## Indications for use
Optina-4C™ is intended to capture images of the retina at multiple wavelengths (colors) under mydriatic conditions.

Source page: https://510kreport.com/device/K231230
Methodology: https://510kreport.com/methodology