FDA 510(k)

BenQ Diagnostic Ultrasound System

K-Number: K181313 · 2018-08-27

Decision Date2018-08-27

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BenQ Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Qisda Corporation. It received FDA 510(k) clearance on 2018-08-27 under 510(k) number K181313. 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 BenQ Diagnostic Ultrasound System?

BenQ Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-08-27. The listed applicant is Qisda Corporation. The 510(k) number is K181313.

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

BenQ Diagnostic Ultrasound System received FDA 510(k) clearance on 2018-08-27, under 510(k) number K181313.

Who is the listed applicant for BenQ Diagnostic Ultrasound System?

The FDA 510(k) record lists Qisda Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Qisda Corporation 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.

K192254InnoSight Diagnostic Ultrasound System K172056InnoSight Diagnostic Ultrasound System

Related Devices (Code: IYN)

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.