4 results
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42ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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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