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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K041577
Device Name PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
Applicant
ADAC LABORATORIES
6400 ENTERPRISE LANE,STE.201
MADISON,  WI  53719
Applicant Contact RANDY VADER
Correspondent
UNDERWRITERS LABORATORIES, INC.
12 LABORATORY DR.
RESEARCH TRIANGLE,  NC  27709
Correspondent Contact WILLIAM J SAMMONS
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
MUJ  
Date Received06/14/2004
Decision Date 06/25/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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