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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
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