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FDA 510(k)

Clarius Ultrasound System

K-Number: K172385 · 2017-09-14

ApplicantClarius Mobile Health Corp.
Decision Date2017-09-14
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Clarius Ultrasound System is a medical device manufactured by Clarius Mobile Health Corp.. It received FDA 510(k) clearance on 2017-09-14 under approval number K172385. 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 System?

Clarius Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-09-14. It is manufactured by Clarius Mobile Health Corp.. The 510(k) number is K172385.

When was Clarius Ultrasound System approved by the FDA?

Clarius Ultrasound System received FDA 510(k) clearance on 2017-09-14, under approval number K172385.

What company makes Clarius Ultrasound System?

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

What is the FDA product code for Clarius Ultrasound System?

The FDA product code for Clarius Ultrasound System is IYN.

Related Clinical Trials

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Other Devices by Clarius Mobile Health Corp.

K163138Clarius Ultrasound System K180799Clarius Ultrasound Scanner K192107Clarius Ultrasound Scanner K213436Clarius Ultrasound Scanner K232257Clarius Bladder AI K232704Clarius Ultrasound Scanner

View all 12 devices →

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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