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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 K260947
Device Name 0.55T 12Ch Breast Coil
Applicant
Neocoil, LLC
N27 W23910a Paul Rd.
Pewaukee,  WI  53072
Applicant Contact Judy Yuan
Correspondent
Neocoil, LLC
N27 W23910A Paul Rd.
Pewaukee,  WI  53072
Correspondent Contact Judy Yuan
Regulation Number892.1000
Classification Product Code
MOS  
Date Received03/23/2026
Decision Date 04/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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