FDA 510(k)

IDx-DR

K-Number: K203629 · 2021-06-10

Decision Date2021-06-10

Product CodePIB

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

IDx-DR is the device name listed in this FDA 510(k) record. The listed applicant is Digital Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-06-10 under 510(k) number K203629. The device is classified under product code PIB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDx-DR?

IDx-DR is a medical device that received FDA 510(k) clearance on 2021-06-10. The listed applicant is Digital Diagnostics, Inc.. The 510(k) number is K203629.

When did IDx-DR receive FDA 510(k) clearance?

IDx-DR received FDA 510(k) clearance on 2021-06-10, under 510(k) number K203629.

Who is the listed applicant for IDx-DR?

The FDA 510(k) record lists Digital Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IDx-DR?

The FDA product code for IDx-DR is PIB.

Other records listing Digital Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213037IDx-DR v2.3

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K253704iPredict-DRiHealthscreen, Inc.K240058AEYE-DSAeye Health, Inc.K223357EyeArt v2.2.0Eyenuk, Inc.K221183AEYE-DSAeye Health, Inc.K213037IDx-DR v2.3Digital Diagnostics, Inc.K200667EyeArtEyenuk, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.