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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 K923851
Device Name ACQSIM SIMULATOR/LOCALIZER
Applicant
Philips Medical Systems (Cleveland), Inc.
5500 Avion Park Dr.
Highland Heights,  OH  44143
Applicant Contact WILLIAM J GERBER
Correspondent
Philips Medical Systems (Cleveland), Inc.
5500 Avion Park Dr.
Highland Heights,  OH  44143
Correspondent Contact WILLIAM J GERBER
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received07/31/1992
Decision Date 10/27/1992
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
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