| K-number | K250770 |
| Device name | Optina-4C (MHRC-C1N) |
| Applicant | Optina Diagnostics, Inc. |
| Product code | HKI |
| Device class | Class II |
| Decision date | Sep 4, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 886.1120 |
The Optina-4C is a non-contact mydriatic fundus camera that captures high-resolution retinal images using hyperspectral imaging technology at 92 wavelengths across the visible and near-infrared spectrum. It processes and displays these images to aid clinicians in detecting, diagnosing, and managing ocular diseases including age-related macular degeneration, retinopathy, and retinal lesions under conditions requiring pupil dilation.
The Optina-4C maintains identical energy source, hardware components, and physical dimensions to the predicate device (MHRC-C1N, K231230). Software enhancements include a new Medical Device Data System for secure image transfer via SFTP and DICOM protocols, a Mean White Generator tool for illumination calibration, operator quality feedback with artifact detection (84% sensitivity/specificity), optic nerve display targeting, and generation of eight new processed retinal image types (NormReg, DeepRed, RedFree, RelSpec, Blue, RGB, HEM, MP) with DICOM conversion capability.
ISO 15004-1:2020 (general ophthalmic instruments), ISO 10940:2009 (fundus camera requirements), ANSI Z80.36:2021 (optical radiation safety), NEMA PS 3.1-3.20:2024 (DICOM), ANSI AAMI ES60601-1:2005 with amendments (electrical safety), IEC 60601-1-2:2020 Edition 4.1 (electromagnetic compatibility), ISO 10993-1:2018 (biocompatibility), and IEC 62304:2006+A1:2015 (software safety class B).
The device is substantially equivalent because it maintains identical hardware and physical specifications to the predicate while adding only software features that underwent security risk assessment and formal verification/validation testing per ISO 62304. All performance testing on the predicate device (spectral accuracy, biocompatibility, consensus standard compliance) remains valid as no changes were made to optical or imaging hardware. The new software features (image processing, artifact detection, DICOM conversion) do not introduce new safety risks and enhance clinical utility without altering the fundamental intended use or mechanism of retinal image acquisition.
View the full FDA submission: accessdata.fda.gov