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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K090808
Device Name PINNACLE3 SMARTARC
Applicant
Philips Medical Systems, Inc.
5520 Nobel Dr.
Suite 125
Fitchburg,  WI  53711
Applicant Contact JILL KAEDER
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received03/25/2009
Decision Date 04/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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