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FDA 510(k)

Clover 50/Clover60/Clover70 Diagnostic Ultrasound System

K-Number: K163712 · 2018-01-02

Decision Date2018-01-02
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Clover 50/Clover60/Clover70 Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Wisonic Medical Technology Co. , Ltd.. It received FDA 510(k) clearance on 2018-01-02 under 510(k) number K163712. 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 Clover 50/Clover60/Clover70 Diagnostic Ultrasound System?

Clover 50/Clover60/Clover70 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-01-02. The listed applicant is Shenzhen Wisonic Medical Technology Co. , Ltd.. The 510(k) number is K163712.

When did Clover 50/Clover60/Clover70 Diagnostic Ultrasound System receive FDA 510(k) clearance?

Clover 50/Clover60/Clover70 Diagnostic Ultrasound System received FDA 510(k) clearance on 2018-01-02, under 510(k) number K163712.

Who is the listed applicant for Clover 50/Clover60/Clover70 Diagnostic Ultrasound System?

The FDA 510(k) record lists Shenzhen Wisonic Medical Technology Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clover 50/Clover60/Clover70 Diagnostic Ultrasound System?

The FDA product code for Clover 50/Clover60/Clover70 Diagnostic Ultrasound System is IYN.

Other records listing Shenzhen Wisonic Medical Technology 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.

View all 7 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.

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.