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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 K162651
Device Name Breast BI 7 MR Coil Mammavention 3T
Applicant
MORAS MRI products GmbH
Leibnizstr. 4
Hoechberg,  DE 97204
Applicant Contact Zahed Sedighiani
Correspondent
MORAS MRI products GmbH
Leibnizstr. 4
Hoechberg,  DE 97204
Correspondent Contact Zahed Sedighiani
Regulation Number892.1000
Classification Product Code
MOS  
Date Received09/23/2016
Decision Date 01/18/2017
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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