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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K212239
Device Name XENOVIEW 3.0T Chest Coil
Applicant
Polarean, Inc.
P.O. Box 14805
Research Triangle Park,  NC  27709
Applicant Contact Neil Wadehra
Correspondent
MethodSense, Inc.
1 Copley Pkwy.,
Suite 410
Morrisville,  NC  27560
Correspondent Contact Rita King
Regulation Number892.1000
Classification Product Code
MOS  
Date Received07/19/2021
Decision Date 12/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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