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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 K222407
Device Name 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast 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 Received08/09/2022
Decision Date 10/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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