# Optina Diagnostics, Inc.

- Location (FDA's records): Montreal, CA
- FDA decisions: 3 (2020–2025): 3 510(k) clearances
- Names in FDA's records: Optina Diagnostics, Inc. (2); Optina Diagnostics (1)
- Product codes: HKI (3)
- 510(k) review time since 2016: median 175 days, against 182 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 3 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Kowa Co., Ltd.: 1 (https://510kreport.com/company/kowa)

## Its most-cited devices
- K231230: Optina-4C (MHRC-C1N) (2023), cited by 1
- K200254: Mydriatic Hyperspectral Retinal Camera (MHRC-C1) (2020), cited by 1

## Recent decisions
- K250770: Optina-4C (MHRC-C1N) (Sep 4, 2025)
- K231230: Optina-4C (MHRC-C1N) (Dec 5, 2023)
- K200254: Mydriatic Hyperspectral Retinal Camera (MHRC-C1) (Apr 27, 2020)

Source page: https://510kreport.com/company/optina-diagnostics