Medical Device Manufacturer · CA , Vancouver

Clarius Mobile Health Corp. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2016

Recent clearances: Clarius Ejection Fraction AI, Clarius Median Nerve AI, Clarius Prostate AI

12
Total
12
Cleared
0
Denied

Clarius Mobile Health Corp. has 12 FDA 510(k) cleared radiology devices. Based in Vancouver, CA.

Latest FDA clearance: Mar 2026. Active since 2016.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant. 4 submissions have an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

FDA 510(k) Regulatory Record - Clarius Mobile Health Corp.

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