Clarius Ejection Fraction AI— 510(k) K253593

Substantially Equivalent

Clarius Mobile Health Corp.

FDA 510(k) clearance K253593 for Clarius Ejection Fraction AI, Substantially Equivalent on 2026-03-02. Applicant: Clarius Mobile Health Corp..

Clearance details

Applicant: Clarius Mobile Health Corp.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2025-11-17
Decision date: 2026-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, CA

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