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FDA 510(k)

iPredict-DR

K-Number: K253704 · 2026-07-02

ApplicantiHealthscreen, Inc.
Decision Date2026-07-02
Product CodePIB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

iPredict-DR is the device name listed in this FDA 510(k) record. The listed applicant is iHealthscreen, Inc.. It received FDA 510(k) clearance on 2026-07-02 under 510(k) number K253704. 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 iPredict-DR?

iPredict-DR is a medical device that received FDA 510(k) clearance on 2026-07-02. The listed applicant is iHealthscreen, Inc.. The 510(k) number is K253704.

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

iPredict-DR received FDA 510(k) clearance on 2026-07-02, under 510(k) number K253704.

Who is the listed applicant for iPredict-DR?

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

What is the FDA product code for iPredict-DR?

The FDA product code for iPredict-DR is PIB.

Related Devices (Code: PIB)

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.

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

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