510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203629Substantially Equivalent

IDx-DR

Digital Diagnostics Inc., Coralville IA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203629 is the FDA 510(k) clearance record for IDx-DR, a class II device, cleared for Digital Diagnostics, Inc. on under FDA product code PIB (Diabetic Retinopathy Detection Device). FDA's definition for product code PIB reads: "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". FDA records list 2 510(k) clearances for Digital Diagnostics, Inc., from to . As of , FDA records show no recalls naming K203629.

Clearance record

Decision date
Received
(181 days to decision)
Product code
PIB Diabetic Retinopathy Detection Device
Regulation
21 CFR 886.1100
Device class
Class II
Review panel
Ophthalmic
Applicant
Digital Diagnostics, Inc. 2300 Oakdale Blvd., Coralville IA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PIB

Trailing 12 months
1 clearance under product code PIB in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PIB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260