Resolve Fundus Camera

The Resolve Fundus Camera is an automatic tabletop camera that captures digital images of the human retina without requiring dilating eye drops. It features automatic pupil tracking, focusing, and image capture to aid clinicians in evaluating and diagnosing eye health. The device uses infrared cameras for observation, an illumination system to locate the fundus, and a main camera with a charge-coupled device (CCD) to capture still images displayed on an internal LCD screen.

The Resolve has a 50-degree field of view (versus predicate's 45 degrees), can work with pupils as small as 3.0 mm (versus 3.8 mm), uses a 15-megapixel CMOS sensor (versus 2.1 megapixel), employs natural white LED illumination with polarization, supports diopter adjustment of +20D/-20D (versus +15D/-15D), and features a 5-inch touchscreen on the camera unit. Both devices are non-mydriatic fundus cameras using auto-alignment and auto-focus, include DICOM compliance, and comply with the same core electrical safety and ophthalmic performance standards.

IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-6 (usability), ANSI Z80.36-2021 (light hazard protection), ISO 10993-1/5/10/23 (biocompatibility), ISO 10940 (fundus camera performance), ISO 15004-1 and ISO 15004-2 (ophthalmic instrument requirements), NEMA PS 3.1-3.20 (DICOM), and IEC 62133-2 (lithium battery safety).

Both devices share identical intended use (digital retinal imaging without mydriasis), same prescription classification, identical product code (HKI), same Class II designation, and equivalent form factor as tabletop cameras with auto-alignment and auto-focus. The Resolve's superior specifications—larger field of view, smaller minimum pupil size, higher megapixel sensor—represent improvements that do not create new safety or performance risks; both devices comply with identical consensus standards for electrical safety, ophthalmic performance, and biocompatibility. Technical improvements in optical and sensor capability do not alter the fundamental technological approach or create new indications or hazards compared to the predicate.