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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
Recalls CDRH Recalls
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