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 a medical device manufactured by Medis Medical Imaging Systems BV. It received FDA 510(k) clearance on 2019-05-30 under approval 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. It is manufactured by Medis Medical Imaging Systems BV. The 510(k) number is K182611.
When was Qangio XA 3D approved by the FDA?
Qangio XA 3D received FDA 510(k) clearance on 2019-05-30, under approval number K182611.
What company makes Qangio XA 3D?
Qangio XA 3D is manufactured by Medis Medical Imaging Systems BV.
What is the FDA product code for Qangio XA 3D?
The FDA product code for Qangio XA 3D is QHA.
Related Devices (Code: QHA)
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.