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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 K955811
Device Name AUXILIARY PATIENT TABLE/MAGNETOM OPEN SYSTEM
Applicant
Siemens Medical Solutions USA, Inc.
186 Wood Ave. S.
Iselin,  NJ  08830
Applicant Contact KATHLEEN RUTHERFORD
Correspondent
Siemens Medical Solutions USA, Inc.
186 Wood Ave. S.
Iselin,  NJ  08830
Correspondent Contact KATHLEEN RUTHERFORD
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/26/1995
Decision Date 03/29/1996
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
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