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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
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.
Product CodePIB
Regulation Number 886.1100
Device Class 2


Premarket Reviews
ManufacturerDecision
AEYE HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 2
DIGITAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
EYENUK, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2025 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Intraocular Pressure Increased 1 1
Glaucoma 1 1

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