FDA 510(k)

CubeVue

K-Number: K181962 · 2018-08-07

Decision Date2018-08-07

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CubeVue is the device name listed in this FDA 510(k) record. The listed applicant is Curvebeam, LLC. It received FDA 510(k) clearance on 2018-08-07 under 510(k) number K181962. 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 CubeVue?

CubeVue is a medical device that received FDA 510(k) clearance on 2018-08-07. The listed applicant is Curvebeam, LLC. The 510(k) number is K181962.

When did CubeVue receive FDA 510(k) clearance?

CubeVue received FDA 510(k) clearance on 2018-08-07, under 510(k) number K181962.

Who is the listed applicant for CubeVue?

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

What is the FDA product code for CubeVue?

The FDA product code for CubeVue is LLZ.

Other records listing Curvebeam, LLC as applicant

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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.