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FDA 510(k)

Paragon XHD Diagnostic Ultrasound System

K-Number: K191347 · 2020-02-07

Decision Date2020-02-07
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Paragon XHD 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 2020-02-07 under 510(k) number K191347. 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 Paragon XHD Diagnostic Ultrasound System?

Paragon XHD Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-02-07. The listed applicant is Shenzhen Wisonic Medical Technology Co. , Ltd.. The 510(k) number is K191347.

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

Paragon XHD Diagnostic Ultrasound System received FDA 510(k) clearance on 2020-02-07, under 510(k) number K191347.

Who is the listed applicant for Paragon XHD 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 Paragon XHD Diagnostic Ultrasound System?

The FDA product code for Paragon XHD 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.