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    MHI-TM2000 LINEAR ACCELERATOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MHI-TM2000 Linear Accelerator System, VERO, Imavis

    FDA 510(k)
    FDA Class 2 ·Radiology

    MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS

    FDA 510(k)
    FDA Class 2 ·Radiology

    VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·December 24, 2014

    MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·August 14, 2013

    VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·April 6, 2016

    MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Hitachi Ltd., Medical System Operations Group·May 9, 2018

    VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·September 24, 2014

    MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·May 13, 2015

    MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·March 30, 2016

    CHEST M.I.,INC.

    Manufacturer
    🇯🇵 Japan·2 Importers

    MPI Inc.

    Manufacturer
    🇯🇵 Japan

    KEISEI MEDICAL INDUSTRIAL CO., LTD.

    Manufacturer
    🇯🇵 Japan·41 Basic UDI-DIs·41 Devices·2 Importers·SGS Belgium NV

    DAIICHI MEDICAL CO., LTD.

    Manufacturer
    🇯🇵 Japan·1 Importer

    POLYAMIDE MONOFILAMENT WITH NEEDLE

    Device
    EU MDD · Eu Md Class 2b ·KEISEI MEDICAL INDUSTRIAL CO., LTD.·On the market·2 countries

    POLYAMIDE MONOFILAMENT WITH NEEDLE

    Device
    EU MDD · Eu Md Class 2b ·KEISEI MEDICAL INDUSTRIAL CO., LTD.·On the market·2 countries

    POLYAMIDE MONOFILAMENT WITH NEEDLE

    Device
    EU MDD · Eu Md Class 2b ·KEISEI MEDICAL INDUSTRIAL CO., LTD.·On the market·2 countries

    POLYAMIDE MONOFILAMENT WITH NEEDLE

    Device
    EU MDD · Eu Md Class 2b ·KEISEI MEDICAL INDUSTRIAL CO., LTD.·On the market·2 countries

    POLYAMIDE MONOFILAMENT WITH NEEDLE

    Device
    EU MDD · Eu Md Class 2b ·KEISEI MEDICAL INDUSTRIAL CO., LTD.·On the market·2 countries

    POLYAMIDE MONOFILAMENT WITH NEEDLE

    Device
    EU MDD · Eu Md Class 2b ·KEISEI MEDICAL INDUSTRIAL CO., LTD.·On the market·2 countries