BEUDAMED
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    Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriate processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is PC based devise that allows for worklist management, image storage, image processing, image exporting and image printing. The system may be equipped with a table and/or vertical wall unit, is configurable with up to two x-ray tubes, and has an auto switching function. This system is intended for use in conjunction with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck and limbs. The system is used for image acquisition, image display and transmission/output or images to external devices.

    FDA Recall
    Terminated ·Canon Medical System, USA, INC.·Product code MQB·October 16, 2018

    Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography.

    FDA Recall
    Terminated ·Canon Medical System, USA, INC.·Product code MQB·February 8, 2019

    Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A

    FDA Recall
    Terminated ·Canon Medical System, USA, INC.·Product code KPS·November 11, 2020

    CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and Infinix-8000H - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

    FDA Recall
    Terminated ·Canon Medical System, USA, INC.·Product code OWB·October 8, 2020

    Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.

    FDA Recall
    Terminated ·Canon Medical System, USA, INC.·Product code JAK·November 9, 2020

    DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)

    FDA Recall
    Terminated ·Canon Medical System, USA, INC.·Product code MQB·April 18, 2018

    Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriate processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is PC based devise that allows for worklist management, image storage, image processing, image exporting and image printing. The system may be equipped with a table and/or vertical wall unit, is configurable with up to two x-ray tubes, and has an auto switching function. This system is intended for use in conjunction with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck and limbs. The system is used for image acquisition, image display and transmission/output or images to external devices.

    FDA Enforcement
    Class II ·Terminated·Canon Medical System, USA, INC.·July 17, 2019

    DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)

    FDA Enforcement
    Class II ·Terminated·Canon Medical System, USA, INC.·September 12, 2018

    Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography.

    FDA Enforcement
    Class II ·Terminated·Canon Medical System, USA, INC.·November 20, 2019

    Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.

    FDA Enforcement
    Class II ·Terminated·Canon Medical System, USA, INC.·December 16, 2020

    CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and Infinix-8000H - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

    FDA Enforcement
    Class II ·Terminated·Canon Medical System, USA, INC.·December 9, 2020

    Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A

    FDA Enforcement
    Class II ·Terminated·Canon Medical System, USA, INC.·October 27, 2021