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U.S. Department of Health and Human Services

Product Classification
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Device diabetic retinopathy detection device
Regulation Description Retinal diagnostic software device.
Definition 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.
Physical State Installed on, and operated by, an off-the-shelf hardware system with an appropriate OS.
Technical Method Software as a medical device designed to analyze digital fundus images taken with an ophthalmic camera. Using artificial intelligence algorithms, the device is able to determine whether a patient has referable retinopathy.
Target Area Fundus images of the macula and optic nerve of the eye.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodePIB
Premarket Review Ophthalmic Devices (DHT1A)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.1100
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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