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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 K013586
Device Name MAGNETOM TRIO SYSTEM
Applicant
SIEMENS MEDICAL SYSTEMS, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Applicant Contact JAMIE YIEH
Correspondent
SIEMENS MEDICAL SYSTEMS, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Correspondent Contact JAMIE YIEH
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/30/2001
Decision Date 12/28/2001
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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