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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 K012202
Device Name NUMARIS 4VA15A
Applicant
SIEMENS MEDICAL CORP.
186 WOOD AVE. SOUTH
ISELIN,  NJ  08830
Applicant Contact JAMIE YIEH
Correspondent
SIEMENS MEDICAL CORP.
186 WOOD AVE. SOUTH
ISELIN,  NJ  08830
Correspondent Contact JAMIE YIEH
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/13/2001
Decision Date 09/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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