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Clarius Mobile Health Corp.: FDA-registered device maker in Vancouver British Columbia, Canada, 12 510(k) clearances

Name: Clarius Mobile Health Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Clarius Mobile Health Corp. is registered with the FDA (registration 3012747207) in Vancouver British Columbia, Canada. It lists 4 device types. The FDA files 12 510(k) clearances under its listings, the newest dated March 2, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012747207
Address: Virtual Way, Vancouver British Columbia, Canada, V5M 4X3
Owner or operator: Clarius Mobile Health Corp. (10053451)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: December 6, 2016
Registered through: 2026
Brand names listed: Basic MSK Ultrasound C7 Scanner, Basic MSK Ultrasound Curvilinear Scanner, Basic MSK Ultrasound Linear Scanner, C3 HD3; C7 HD3; EC7 HD3; L7 HD3; L15 HD3; PA HD3; L20 HD3; Clarius Fan HD3; Clarius Power Fan HD3; Clarius Charger HD3, Clarius AI, Clarius Battery, Clarius Battery HD, Clarius Bladder AI and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 2, 2026	K253593	Clarius Ejection Fraction AI	QIH	Substantially Equivalent	Clarius Mobile Health Corp.	accessdata.fda.gov
May 8, 2025	K250226	Clarius Median Nerve AI	QIH	Substantially Equivalent	Clarius Mobile Health Corp.	accessdata.fda.gov
April 16, 2025	K243853	Clarius Prostate AI	QIH	Substantially Equivalent	Clarius Mobile Health Corp.	accessdata.fda.gov
June 14, 2024	K233955	Clarius OB AI	IYN	Substantially Equivalent	Clarius Mobile Health Corp.	accessdata.fda.gov
November 13, 2023	K232257	Clarius Bladder AI	QIH	Substantially Equivalent	Clarius Mobile Health Corp.	accessdata.fda.gov
October 5, 2023	K232704	Clarius Ultrasound Scanner	IYN	Substantially Equivalent	Clarius Mobile Health Corp.	accessdata.fda.gov
January 23, 2023	K222406	Clarius AI	QIH	Substantially Equivalent	Clarius Mobile Health Corp.	accessdata.fda.gov
November 15, 2021	K213436	Clarius Ultrasound Scanner	IYN	Substantially Equivalent	Clarius Mobile Health Corp.	accessdata.fda.gov
August 29, 2019	K192107	Clarius Ultrasound Scanner	IYN	Substantially Equivalent	Clarius Mobile Health Corp.	accessdata.fda.gov
May 14, 2018	K180799	Clarius Ultrasound Scanner	IYN	Substantially Equivalent	Clarius Mobile Health Corp.	accessdata.fda.gov
September 14, 2017	K172385	Clarius Ultrasound System	IYN	Substantially Equivalent	Clarius Mobile Health Corp.	accessdata.fda.gov
November 30, 2016	K163138	Clarius Ultrasound System	IYN	Substantially Equivalent	Clarius Mobile Health Corp.	accessdata.fda.gov

Compare with other makers

Updated March 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.