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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,  JP 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 (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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