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Diabetic Retinopathy Detection Device

FDA product code PIB · 7 cleared devices

Class 2 Ophthalmic
Regulation
21 CFR 886.1100
Review panel
OP
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2020-08-03 – 2026-07-02

A retinal diagnostic software device is a prescription software device that incorporates an adaptive algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions.

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