Clarius Ejection Fraction AI— 510(k) K253593

Name: FDA 510(k) clearance K253593
Creator: U.S. Food and Drug Administration
Published: 2026-03-02

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.. Device class: 2.

Clearance details

Applicant: Clarius Mobile Health Corp.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-11-17
Decision date: 2026-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, CA

Download summary PDF View on FDA.gov ↗

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More clearances from Clarius Mobile Health Corp.

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K250226 — Clarius Median Nerve AI2025-05-08
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K232704 — Clarius Ultrasound Scanner2023-10-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.