MHI-TM2000 LINEAR ACCELERATOR SYSTEM

Accelerator, Linear, Medical

MITSUBISHI HEAVY INDUSTRIES, LTD.

The following data is part of a premarket notification filed by Mitsubishi Heavy Industries, Ltd. with the FDA for Mhi-tm2000 Linear Accelerator System.

Pre-market Notification Details

Device IDK072047
510k NumberK072047
Device Name:MHI-TM2000 LINEAR ACCELERATOR SYSTEM
ClassificationAccelerator, Linear, Medical
Applicant MITSUBISHI HEAVY INDUSTRIES, LTD. 4-6-22 KAN-ON-SHIN-MACHI NISHI-KU Hiroshima-shi,  JP 733-8553
ContactTakashi Yamakawa
CorrespondentTakashi Yamakawa
MITSUBISHI HEAVY INDUSTRIES, LTD. 4-6-22 KAN-ON-SHIN-MACHI NISHI-KU Hiroshima-shi,  JP 733-8553
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-25
Decision Date2007-08-29

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