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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K130992
Device Name PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
Applicant
Philips Medical Systems (Cleveland), Inc.
816 Congress Ave. Suite 1400
Austin,  TX  78701
Applicant Contact DIANE SUDDUTH
Correspondent
Philips Medical Systems (Cleveland), Inc.
816 Congress Ave. Suite 1400
Austin,  TX  78701
Correspondent Contact DIANE SUDDUTH
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/10/2013
Decision Date 06/14/2013
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
Recalls CDRH Recalls
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