Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Clarius Ultrasound System

K-Number: K163138 · 2016-11-30

ApplicantClarius Mobile Health Corp.
Decision Date2016-11-30
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Clarius Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Clarius Mobile Health Corp.. It received FDA 510(k) clearance on 2016-11-30 under 510(k) number K163138. 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 2016-11-30. The listed applicant is Clarius Mobile Health Corp.. The 510(k) number is K163138.

When did Clarius Ultrasound System receive FDA 510(k) clearance?

Clarius Ultrasound System received FDA 510(k) clearance on 2016-11-30, under 510(k) number K163138.

Who is the listed applicant for Clarius Ultrasound System?

The FDA 510(k) record lists Clarius Mobile Health Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clarius Ultrasound System?

The FDA product code for Clarius Ultrasound System is IYN.

Other records listing Clarius Mobile Health Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253593Clarius Ejection Fraction AIK250226Clarius Median Nerve AIK243853Clarius Prostate AIK233955Clarius OB AIK232257Clarius Bladder AIK232704Clarius Ultrasound Scanner

View all 12 devices →

Related Devices (Code: IYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261835LOGIQ FocusGE Medical Systems Ultrasound and Primary Care DiagnosticsK261288Handheld Ultrasound ScannerIMGFAX CO., LTD.K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System;Samsung Medison Co., Ltd.K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCK261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound systemEsonic Technology (Wuhan) Co., Ltd.K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd

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.

↑