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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,  JP 733-8553
Applicant Contact YOICHI WAKIYAMA
Correspondent
MITSUBISHI HEAVY INDUSTRIES, LTD.
4-6-22 KAN-ON-SHIN-MACHI
NISHI-KU
HIROSHIMA-SHI,  JP 733-8553
Correspondent 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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