510(k) K253704— iPredict-DR

Substantially Equivalent

iHealthscreen, Inc.

Clearance details

Applicant: iHealthscreen, Inc.
Product code: Code PIB
Advisory panel: Ophthalmic
Date received: 2025-11-24
Decision date: 2026-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond Hill, NY, US

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