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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 K112060
Device Name RADIANCE
Original Applicant
GMV AEROSPACE AND DEFENCE S.A.
220 river road
claremont,  NH  03743
Original Contact william greenrose
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received07/19/2011
Decision Date 01/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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