Ophthalmology
CLARUS
Carl Zeiss Meditec, Inc
FDA-cleared AI medical device
An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
FDA Submission Metadata
- Submission number
- K191194
- Decision date
- June 2019
- FDA panel
- Ophthalmic
- Product code
- QER
- Clinical task (npj)
- quantification/feature localization
- Data modality (npj)
- Images
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.