FDA 510(k)

Kuvia3D

K-Number: K161559 · 2016-06-23

Decision Date2016-06-23

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Kuvia3D is the device name listed in this FDA 510(k) record. The listed applicant is 4qimaging, LLC Dba Qmetrics. It received FDA 510(k) clearance on 2016-06-23 under 510(k) 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. The listed applicant is 4qimaging, LLC Dba Qmetrics. The 510(k) number is K161559.

When did Kuvia3D receive FDA 510(k) clearance?

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

Who is the listed applicant for Kuvia3D?

The FDA 510(k) record lists 4qimaging, LLC Dba Qmetrics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kuvia3D?

The FDA product code for Kuvia3D is LLZ.

Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLC K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid StreamVueCandelis, Inc.

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.