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510(k) K203629

IDx-DR by Digital Diagnostics, Inc. — Product Code PIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2021
Date Received
December 11, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diabetic Retinopathy Detection Device
Device Class
Class II
Regulation Number
886.1100
Review Panel
OP
Submission Type

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.

Other clearances by Digital Diagnostics, Inc.

  • K213037 — IDx-DR v2.3 (June 17, 2022)

Other clearances for product code PIB

  • K240058 — AEYE-DS (April 23, 2024)
  • K223357 — EyeArt v2.2.0 (June 16, 2023)
  • K221183 — AEYE-DS (November 10, 2022)
  • K213037 — IDx-DR v2.3 (June 17, 2022)
  • K200667 — EyeArt (August 3, 2020)
  • DEN180001 — IDx-DR (April 11, 2018)