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    EOS imaging

    Manufacturer
    🇫🇷 France·3 Basic UDI-DIs·5 Devices

    EOS imaging

    FDA registration
    EOS imaging·4 products·🇫🇷 France

    EOSedge Chair

    Device
    EU MDR · Eu Md Class 1 ·EOS imaging·On the market·4 countries

    sterEOS

    Device
    EU MDR · Eu Md Class 2a ·EOS imaging·On the market·15 countries

    sterEOS

    Device
    EU MDR · Eu Md Class 2a ·EOS imaging·On the market·1 country

    Radioluscent chair

    Device
    EU MDR · Eu Md Class 1 ·EOS imaging·On the market·4 countries

    sterEOS

    Device
    EU MDR · Eu Md Class 2a ·EOS imaging·On the market·15 countries

    Radioluscent Chair

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·EOS imaging·1 device

    EOSedge Chair

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·EOS imaging·1 device

    sterEOS

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·EOS imaging·3 devices

    steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·January 1, 2014

    ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774.

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·July 5, 2017

    EOS System X- ray beam Digital radiography system used in general radiographic examinations.

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·January 15, 2014

    sterEOS workstation

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·September 26, 2018

    The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific area (spine, lower limbs, etc.). EOSedge consists of a gantry and an acquisition workstation. ¿ The gantry contains two orthogonal acquisition units, each of which comprises an X-ray source (high frequency generator + X-ray tube + collimator) and an X-ray detection system (detector + electronics). ¿ The acquisition workstation and its software control the generators and detectors. It is also used to enter patient data, via RIS/HIS or manually, to define acquisition parameters, process images and record images in DICOM 3.0 format. The intended use/indications for use, technological characteristics, and principles of operation of the EOSedge system are described below.

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·April 21, 2021