BEUDAMED
    8 results · 15ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical

    FDA Enforcement
    Class II ·Terminated·NeuroLogica Corporation·April 25, 2018

    Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications

    FDA Enforcement
    Class II ·Terminated·NeuroLogica Corporation·September 6, 2017

    Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.

    FDA Enforcement
    Class II ·Terminated·NeuroLogica Corporation·November 18, 2015

    The GC80 Digital X-ray Imaging System

    FDA Enforcement
    Class II ·Terminated·NeuroLogica Corporation·March 14, 2018

    Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications

    FDA Enforcement
    Class II ·Terminated·NeuroLogica Corporation·June 5, 2019

    WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00, 3.01.01, 3.01.02, 3.01.03, 3.01.04, 3.01.05, 3.01.06, 3.01.07, 3.01.08, 3.01.09, 4.00.08, 4.00.09, 4.00.10, 4.00.11, 4.01.00, 4.01.01, 4.01.02, 4.01.03, 4.01.04, 4.01.05, 4.01.06, 4.01.07, 4.01.08, 4.01.09.

    FDA Enforcement
    Class II ·Terminated·NeuroLogica Corporation·August 21, 2019

    HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.12

    FDA Enforcement
    Class II ·Terminated·NeuroLogica Corporation·August 21, 2019

    OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.

    FDA Enforcement
    Class II ·Terminated·NeuroLogica Corporation·August 19, 2020