4 results
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39ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
FDA Recall
Terminated
·Vision Rt Inc·Product code IYE·October 15, 2014
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.
FDA Recall
Terminated
·Vision Rt Inc·Product code IYE·November 11, 2014
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.
FDA Enforcement
Class II
·Terminated·Vision Rt Inc·January 14, 2015
AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
FDA Enforcement
Class II
·Terminated·Vision Rt Inc·December 3, 2014