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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 K782005
Device Name RADIATION ONCOLOGY SYSTEM
Original Applicant
ADAC LABORATORIES
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received12/04/1978
Decision Date 12/20/1978
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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