BEUDAMED
    8 results · 30ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    AIRO Mobile CT System Model # MobiCT-32

    FDA Recall
    Terminated ·Mobius Imaging, LLC·Product code JAK·August 1, 2018

    AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).

    FDA Recall
    Terminated ·Mobius Imaging, LLC·Product code JAK·September 26, 2017

    Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.

    FDA Recall
    Terminated ·Mobius Imaging, LLC·Product code JAK·December 8, 2014

    MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1

    FDA Recall
    Terminated ·Mobius Imaging, LLC·Product code JAK·November 18, 2022

    Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.

    FDA Enforcement
    Class II ·Terminated·Mobius Imaging, LLC·February 4, 2015

    AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).

    FDA Enforcement
    Class II ·Terminated·Mobius Imaging, LLC·March 7, 2018

    AIRO Mobile CT System Model # MobiCT-32

    FDA Enforcement
    Class II ·Terminated·Mobius Imaging, LLC·September 26, 2018

    MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1

    FDA Enforcement
    Class II ·Terminated·Mobius Imaging, LLC·December 7, 2022