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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device diabetic retinopathy detection 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.
Product CodePIB
Regulation Number 886.1100
Device Class 2


Premarket Reviews
ManufacturerDecision
IDX, LLC
  GRANTED 1


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