FDA 510(k)

WS80A Diagnostic Ultrasound System

K-Number: K171070 · 2017-08-09

Decision Date2017-08-09

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

WS80A Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Medison Co., Ltd.. It received FDA 510(k) clearance on 2017-08-09 under 510(k) number K171070. 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 WS80A Diagnostic Ultrasound System?

WS80A Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-08-09. The listed applicant is Samsung Medison Co., Ltd.. The 510(k) number is K171070.

When did WS80A Diagnostic Ultrasound System receive FDA 510(k) clearance?

WS80A Diagnostic Ultrasound System received FDA 510(k) clearance on 2017-08-09, under 510(k) number K171070.

Who is the listed applicant for WS80A Diagnostic Ultrasound System?

The FDA 510(k) record lists Samsung Medison Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WS80A Diagnostic Ultrasound System?

The FDA product code for WS80A Diagnostic Ultrasound System is IYN.

Other records listing Samsung Medison Co., Ltd. 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.

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Related Devices (Code: IYN)

Official Source

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