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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K130885
Device Name MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT
Applicant
Siemens Medical Solutions USA, Inc.
757 A Arnold Dr.
Martinez,  CA  94553
Applicant Contact CHRISTINE DUNBAR
Correspondent
Siemens Medical Solutions USA, Inc.
757 A Arnold Dr.
Martinez,  CA  94553
Correspondent Contact CHRISTINE DUNBAR
Regulation Number892.1000
Classification Product Code
LNH  
Date Received03/29/2013
Decision Date 05/17/2013
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
Recalls CDRH Recalls
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