FDA 510(k)

IDx-DR v2.3

K-Number: K213037 · 2022-06-17

Decision Date2022-06-17

Product CodePIB

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

IDx-DR v2.3 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 2022-06-17 under 510(k) number K213037. 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 v2.3?

IDx-DR v2.3 is a medical device that received FDA 510(k) clearance on 2022-06-17. The listed applicant is Digital Diagnostics, Inc.. The 510(k) number is K213037.

When did IDx-DR v2.3 receive FDA 510(k) clearance?

IDx-DR v2.3 received FDA 510(k) clearance on 2022-06-17, under 510(k) number K213037.

Who is the listed applicant for IDx-DR v2.3?

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 v2.3?

The FDA product code for IDx-DR v2.3 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.

K203629IDx-DR

Related Devices (Code: PIB)

K253704iPredict-DRiHealthscreen, Inc.K240058AEYE-DSAeye Health, Inc.K223357EyeArt v2.2.0Eyenuk, Inc.K221183AEYE-DSAeye Health, Inc.K203629IDx-DRDigital Diagnostics, Inc.K200667EyeArtEyenuk, Inc.

Official Source

View on FDA Database →

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