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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accelerator, linear, medical
510(K) Number K122450
Device Name MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS
Applicant
MITSUBISHI HEAVY INDUSTRIES, LTD.
4-6-22 kan-on-shin-machi
nishi-ku
hiroshima-shi, 
Contact yoichi wakiyama
Regulation Number892.5050
Classification Product Code
IYE  
Date Received08/13/2012
Decision Date 10/03/2012
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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