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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 K970852
Device Name MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE)
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVE. SOUTH
ISELIN,  NJ  08830
Applicant Contact KATHLEEN RUTHERFORD
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVE. SOUTH
ISELIN,  NJ  08830
Correspondent Contact KATHLEEN RUTHERFORD
Regulation Number892.1000
Classification Product Code
LNH  
Date Received03/07/1997
Decision Date 06/05/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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