Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
AEYE HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIGITAL DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 2
EYENUK, INC
  SUBSTANTIALLY EQUIVALENT 1
EYENUK, INC.
  SUBSTANTIALLY EQUIVALENT 1
IDX, LLC
  GRANTED 1

-
-