FDA 510(k)

Clarius OB AI

K-Number: K233955 · 2024-06-14

Decision Date2024-06-14

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Clarius OB AI is a medical device manufactured by Clarius Mobile Health Corp.. It received FDA 510(k) clearance on 2024-06-14 under approval number K233955. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Clarius OB AI?

Clarius OB AI is a medical device that received FDA 510(k) clearance on 2024-06-14. It is manufactured by Clarius Mobile Health Corp.. The 510(k) number is K233955.

When was Clarius OB AI approved by the FDA?

Clarius OB AI received FDA 510(k) clearance on 2024-06-14, under approval number K233955.

What company makes Clarius OB AI?

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

What is the FDA product code for Clarius OB AI?

The FDA product code for Clarius OB AI is IYN.

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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Related Devices (Code: IYN)

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd. K163138Clarius Ultrasound SystemClarius Mobile Health Corp. K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics K162583ALOKA LISENDO 880Hitachi , Ltd. K163020Xperius Ultrasound SystemPhilips Health Care

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.