FDA 510(k)

XENOVIEW 3.0T Chest Coil

K-Number: K212239 · 2022-12-23

Decision Date2022-12-23

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

XENOVIEW 3.0T Chest Coil is a medical device manufactured by Polarean, Inc.. It received FDA 510(k) clearance on 2022-12-23 under approval number K212239. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XENOVIEW 3.0T Chest Coil?

XENOVIEW 3.0T Chest Coil is a medical device that received FDA 510(k) clearance on 2022-12-23. It is manufactured by Polarean, Inc.. The 510(k) number is K212239.

When was XENOVIEW 3.0T Chest Coil approved by the FDA?

XENOVIEW 3.0T Chest Coil received FDA 510(k) clearance on 2022-12-23, under approval number K212239.

What company makes XENOVIEW 3.0T Chest Coil?

XENOVIEW 3.0T Chest Coil is manufactured by Polarean, Inc..

What is the FDA product code for XENOVIEW 3.0T Chest Coil?

The FDA product code for XENOVIEW 3.0T Chest Coil is MOS.

Other Devices by Polarean, Inc.

K223071Xenoview VDP K231647XENOVIEW 3.0T Chest Coil K243316XENOVIEW 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.