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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
Original Applicant
MITSUBISHI HEAVY INDUSTRIES, LTD.
4-6-22 kan-on-shin-machi
nishi-ku
hiroshima-shi,  JA 733-8553
Original 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
Recalls CDRH Recalls
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