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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 K032724
Device Name PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
Applicant
Adac Laboratories
6400 Enterprise Lane,Suite 201
Madison,  WI  53719
Applicant Contact RANDY VADER
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF RONGERO
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received09/03/2003
Decision Date 10/09/2003
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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