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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 K020991
Device Name SYNGO MR 2002B
Applicant
Siemens Medical Solutions USA, Inc.
186 Wood Ave. S.
Iselin,  NJ  08830
Applicant Contact JAMIE YIEH
Correspondent
Siemens Medical Solutions USA, Inc.
186 Wood Ave. S.
Iselin,  NJ  08830
Correspondent Contact JAMIE YIEH
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LNI  
Date Received03/27/2002
Decision Date 06/13/2002
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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