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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 K152867
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,  JP 733-8553
Applicant Contact KATSUHISA TOYAMA
Correspondent
Mitsubishi Heavy Industries, Ltd.
4-6-22 Kan-On-Shin-Machi
Nishi-Ku
Hiroshima-Shi,  JP 733-8553
Correspondent Contact KATSUHISA TOYAMA
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/30/2015
Decision Date 10/21/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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