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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 K201101
Device Name 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil
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 Received04/24/2020
Decision Date 06/02/2020
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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