Clarius AI— 510(k) K222406

Substantially Equivalent

Clarius Mobile Health Corp.

FDA 510(k) clearance K222406 for Clarius AI, Substantially Equivalent on 2023-01-23. 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: 2022-08-09
Decision date: 2023-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

K260879 — 4DM2026-09-10
K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

More clearances from Clarius Mobile Health Corp.

K253593 — Clarius Ejection Fraction AI2026-03-02
K250226 — Clarius Median Nerve AI2025-05-08
K243853 — Clarius Prostate AI2025-04-16
K233955 — Clarius OB AI2024-06-14
K232257 — Clarius Bladder AI2023-11-13

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