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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Simulation, Radiation Therapy
510(k) Number K946053
Device Name SIMVIEW(TM) 3000
Applicant
Siemens Medical Solutions USA, Inc.
4040 Nelson Ave.
Concord,  CA  94520
Applicant Contact KENNETH R MICHAEL
Correspondent
Siemens Medical Solutions USA, Inc.
4040 Nelson Ave.
Concord,  CA  94520
Correspondent Contact KENNETH R MICHAEL
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received12/12/1994
Decision Date 03/31/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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