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FDA 510(k)

Kuvia3D

K-Number: K161559 · 2016-06-23

Decision Date2016-06-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Kuvia3D is a medical device manufactured by 4qimaging, LLC Dba Qmetrics. It received FDA 510(k) clearance on 2016-06-23 under approval number K161559. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kuvia3D?

Kuvia3D is a medical device that received FDA 510(k) clearance on 2016-06-23. It is manufactured by 4qimaging, LLC Dba Qmetrics. The 510(k) number is K161559.

When was Kuvia3D approved by the FDA?

Kuvia3D received FDA 510(k) clearance on 2016-06-23, under approval number K161559.

What company makes Kuvia3D?

Kuvia3D is manufactured by 4qimaging, LLC Dba Qmetrics.

What is the FDA product code for Kuvia3D?

The FDA product code for Kuvia3D is LLZ.

Related Devices (Code: LLZ)

Official Source

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