FDA 510(k)

Qangio XA 3D

K-Number: K182611 · 2019-05-30

ApplicantMedis Medical Imaging Systems BV

Decision Date2019-05-30

Product CodeQHA

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Qangio XA 3D is the device name listed in this FDA 510(k) record. The listed applicant is Medis Medical Imaging Systems BV. It received FDA 510(k) clearance on 2019-05-30 under 510(k) number K182611. The device is classified under product code QHA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Qangio XA 3D?

Qangio XA 3D is a medical device that received FDA 510(k) clearance on 2019-05-30. The listed applicant is Medis Medical Imaging Systems BV. The 510(k) number is K182611.

When did Qangio XA 3D receive FDA 510(k) clearance?

Qangio XA 3D received FDA 510(k) clearance on 2019-05-30, under 510(k) number K182611.

Who is the listed applicant for Qangio XA 3D?

The FDA 510(k) record lists Medis Medical Imaging Systems BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Qangio XA 3D?

The FDA product code for Qangio XA 3D is QHA.

Related Devices (Code: QHA)

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.

K251355X1-FFRSpectrawave, Inc.K243769QFR (3.0)Qfr Solutions BV K232147CAAS WorkstationPie Medical Imaging BV K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.K221711AccuICASArteryFlow Technology Co., Ltd.K210093AccuFFRangioArteryFlow 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.