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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 K180123
Device Name Breast BI 7 MR Coil 1.5T Mammavention
Applicant
Noras MRI products GmbH
Leibnizstrasse 4
Hoechberg,  DE 97204
Applicant Contact Jens Heidenmann
Correspondent
Noras MRI products GmbH
Leibnizstrasse 4
Hoechberg,  DE 97204
Correspondent Contact Jens Heidenmann
Regulation Number892.1000
Classification Product Code
MOS  
Date Received01/16/2018
Decision Date 02/16/2018
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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