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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 K072047
Device Name MHI-TM2000 LINEAR ACCELERATOR SYSTEM
Applicant
MITSUBISHI HEAVY INDUSTRIES, LTD.
4-6-22 KAN-ON-SHIN-MACHI
NISHI-KU
HIROSHIMA-SHI,  JP 733-8553
Applicant Contact TAKASHI YAMAKAWA
Correspondent
MITSUBISHI HEAVY INDUSTRIES, LTD.
4-6-22 KAN-ON-SHIN-MACHI
NISHI-KU
HIROSHIMA-SHI,  JP 733-8553
Correspondent Contact TAKASHI YAMAKAWA
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/25/2007
Decision Date 08/29/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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