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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 K213687
Device Name 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch
Applicant
Neocoil, LLC
N27 W23910a Paul Rd.
Pewaukee,  WI  53072
Applicant Contact Katie Gonzalez
Correspondent
Neocoil, LLC
N27 W23910a Paul Rd.
Pewaukee,  WI  53072
Correspondent Contact Katie Gonzalez
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/23/2021
Decision Date 03/11/2022
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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