FDA 510(k)

Xenoview VDP

K-Number: K223071 · 2022-12-23

Decision Date2022-12-23

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Xenoview VDP is the device name listed in this FDA 510(k) record. The listed applicant is Polarean, Inc.. It received FDA 510(k) clearance on 2022-12-23 under 510(k) number K223071. 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 Xenoview VDP?

Xenoview VDP is a medical device that received FDA 510(k) clearance on 2022-12-23. The listed applicant is Polarean, Inc.. The 510(k) number is K223071.

When did Xenoview VDP receive FDA 510(k) clearance?

Xenoview VDP received FDA 510(k) clearance on 2022-12-23, under 510(k) number K223071.

Who is the listed applicant for Xenoview VDP?

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

What is the FDA product code for Xenoview VDP?

The FDA product code for Xenoview VDP is LLZ.

Other records listing Polarean, Inc. as applicant

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.

K243316XENOVIEW 3.0T Chest Coil K231647XENOVIEW 3.0T Chest Coil K212239XENOVIEW 3.0T Chest Coil

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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.