Verily Numetric Retinal Camera
Verily Life Sciences, LLCThe Verily Numetric Retinal Camera is a non-contact, high resolution digital imaging device designed to photograph, display, and store images of the retina under non-mydriatic conditions. It aids clinicians in the evaluation, diagnosis, and documentation of ocular health by providing high quality retinal images.
Intended Use
Verily Numetric Retinal Camera is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina segment of the eye to be evaluated under non-mydriatic conditions. It is indicated for in-vivo viewing of the posterior segment of the eye to aid clinicians in the evaluation, diagnosis, and documentation of ocular health.
Technology
The Verily Numetric Retinal Camera is a tabletop fundus camera that uses a microdisplay for interactive focusing by the patient, eye-tracking for alignment, and captures color fundus images illuminated by LEDs, detected by a color CMOS sensor. It operates non-mydriatically and ensures image quality comparable to predicate devices.
Performance
Performance testing demonstrated that the Verily Numetric Retinal Camera meets image quality and safety standards comparable to its predicate device (NFC-700), including resolution, field of view, pupil size, focus range, and illumination safety. Software validation confirmed compliance with IEC 62304 standards, and device performance adheres to ISO and ANSI standards relevant to ophthalmic cameras.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/22/2024
3 months - 2
FDA Approval
12/9/2024
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