FDA 510(k)

Clarius Bladder AI

K-Number: K232257 · 2023-11-13

Decision Date2023-11-13

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Clarius Bladder AI is a medical device manufactured by Clarius Mobile Health Corp.. It received FDA 510(k) clearance on 2023-11-13 under approval number K232257. 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 Bladder AI?

Clarius Bladder AI is a medical device that received FDA 510(k) clearance on 2023-11-13. It is manufactured by Clarius Mobile Health Corp.. The 510(k) number is K232257.

When was Clarius Bladder AI approved by the FDA?

Clarius Bladder AI received FDA 510(k) clearance on 2023-11-13, under approval number K232257.

What company makes Clarius Bladder AI?

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

What is the FDA product code for Clarius Bladder AI?

The FDA product code for Clarius Bladder 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 K232704Clarius Ultrasound Scanner

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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.