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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 K032428
Device Name MAGNETOM AVANTO MR SYSTEM
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MALVERN,  PA  19355 -1406
Applicant Contact NEALIE HARTMAN
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MALVERN,  PA  19355 -1406
Correspondent Contact NEALIE HARTMAN
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LNI  
Date Received07/29/2003
Decision Date 10/16/2003
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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