FDA 510(k)

Clarius Prostate AI

K-Number: K243853 · 2025-04-16

Decision Date2025-04-16

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Clarius Prostate AI is a medical device manufactured by Clarius Mobile Health Corp.. It received FDA 510(k) clearance on 2025-04-16 under approval number K243853. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Clarius Prostate AI?

Clarius Prostate AI is a medical device that received FDA 510(k) clearance on 2025-04-16. It is manufactured by Clarius Mobile Health Corp.. The 510(k) number is K243853.

When was Clarius Prostate AI approved by the FDA?

Clarius Prostate AI received FDA 510(k) clearance on 2025-04-16, under approval number K243853.

What company makes Clarius Prostate AI?

Clarius Prostate AI is manufactured by Clarius Mobile Health Corp..

What is the FDA product code for Clarius Prostate AI?

The FDA product code for Clarius Prostate AI is QIH.

Other Devices by Clarius Mobile Health Corp.

K163138Clarius Ultrasound System K172385Clarius Ultrasound System K180799Clarius Ultrasound Scanner K192107Clarius Ultrasound Scanner K213436Clarius Ultrasound Scanner K232257Clarius Bladder AI

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.