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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 K953233
Device Name SIMVIEW 3000 CT OPTION
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 NELSON AVE.
CONCORD,  CA  94520
Applicant Contact KENNETH MICHAEL
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 NELSON AVE.
CONCORD,  CA  94520
Correspondent Contact KENNETH MICHAEL
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received07/10/1995
Decision Date 11/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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