BEUDAMED
    15 results · 47ms · 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 Regulation: Us FDA ×

    Vision RT Ltd

    FDA registration
    Vision RT Ltd·2 products·🇬🇧 United Kingdom

    ALIGNRT

    FDA Adverse Event
    Malfunction ·VISION RT LTD·Product code IYE·October 22, 2014

    ALIGNRT PLUS

    FDA Adverse Event
    Malfunction ·VISION RT LTD.·Product code IYE·August 11, 2021

    ALIGNRT PLUS

    FDA Adverse Event
    Malfunction ·VISION RT LTD·Product code IYE·July 13, 2021

    ALIGNRT

    FDA Adverse Event
    Malfunction ·VISION RT LTD·Product code IYE·December 18, 2013

    ALIGNRT

    FDA Adverse Event
    Malfunction ·VISION RT LTD·Product code IYE·December 18, 2013

    AlignRT Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

    FDA Recall
    Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

    TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Recall
    Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

    GATERT

    FDA Adverse Event
    Malfunction ·ION RT LTD., VISION RT LIMITED·Product code IYE·February 9, 2016

    AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.

    FDA Enforcement
    Class II ·Ongoing·Vision RT Ltd·January 14, 2026

    Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·October 10, 2018

    Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172

    FDA Recall
    Terminated ·Vision RT Ltd Dove House Arcadia Avenue London United Kingdom·Product code IYE·August 24, 2018

    The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.

    FDA Recall
    Open, Classified ·Vision RT Ltd Dove House Arcadia Avenue London United Kingdom·Product code IWE·August 27, 2025