510(k) · Ophthalmic

IDx-DR

by Digital Diagnostics Inc.

IDx-DR is an AI-enabled medical device from Digital Diagnostics Inc. that the U.S. FDA cleared through 510(k) K203629 on June 10, 2021. Its lead review panel is Ophthalmic and its primary product code is PIB (Diabetic Retinopathy Detection Device).

See also all FDA AI clearances in 2021.

Key facts

Submission numberK203629
Pathway510(k)
Date of final decision
Company (FDA list)Digital Diagnostics Inc.
Lead review panelOphthalmic
Primary product codePIB — Diabetic Retinopathy Detection Device
Applicant (openFDA)Digital Diagnostics, Inc.
Applicant locationCoralville, IA, US
Device classClass 2
Regulation number21 CFR 886.1100
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. IDx-DR went through this pathway (K203629).

openFDA lists it as a Class 2 device under 21 CFR 886.1100. Class II devices are moderate risk and are subject to general and special controls.

Product code PIB covers 7 devices on the FDA AI list. By decision date, this device is #3 of 7 under that code. Digital Diagnostics Inc. has 2 AI-enabled devices on the list, and the Ophthalmic panel accounts for 10 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

Similar devices (product code PIB)

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