510(k) Report

Devices descending from DEN180001

7 later devices reach IDx-DR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221183Aeye-DSAeye Health, Inc.20221—
+1K203629IDx-DRDigital Diagnostics, Inc.20212—
+1K200667EyeArtEyenuk, Inc.20201—
+2K253704iPredict-DRiHealthscreen, Inc.20260—
+2K240058Aeye-DSAeye Health, Inc.20240—
+2K223357EyeArt v2.2.0Eyenuk, Inc.20230—
+2K213037IDx-DR v2.3Digital Diagnostics, Inc.20220—