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FDA 510(k)

Clarius Ultrasound Scanner

K-Number: K213436 · 2021-11-15

ApplicantClarius Mobile Health Corp.
Decision Date2021-11-15
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Clarius Ultrasound Scanner is a medical device manufactured by Clarius Mobile Health Corp.. It received FDA 510(k) clearance on 2021-11-15 under approval number K213436. 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 Ultrasound Scanner?

Clarius Ultrasound Scanner is a medical device that received FDA 510(k) clearance on 2021-11-15. It is manufactured by Clarius Mobile Health Corp.. The 510(k) number is K213436.

When was Clarius Ultrasound Scanner approved by the FDA?

Clarius Ultrasound Scanner received FDA 510(k) clearance on 2021-11-15, under approval number K213436.

What company makes Clarius Ultrasound Scanner?

Clarius Ultrasound Scanner is manufactured by Clarius Mobile Health Corp..

What is the FDA product code for Clarius Ultrasound Scanner?

The FDA product code for Clarius Ultrasound Scanner is IYN.

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Other Devices by Clarius Mobile Health Corp.

K163138Clarius Ultrasound System K172385Clarius Ultrasound System K180799Clarius Ultrasound Scanner K192107Clarius Ultrasound Scanner K232257Clarius Bladder AI K232704Clarius Ultrasound Scanner

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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.

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