7 results
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6ms
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Sources: EU EUDAMED, US FDA
CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Completed·Accuray Incorporated·February 5, 2025
VariCam
FDA Enforcement
Class II
·Completed·GE Healthcare, LLC·January 16, 2019
Discover VH/Millennium VG Nuclear Medicine Imaging System
FDA Enforcement
Class II
·Completed·GE Healthcare, LLC·January 16, 2019
Discovery NM/CT 670 Pro, model 5376204-70-54
FDA Enforcement
Class II
·Completed·GE Healthcare, LLC·December 19, 2018
Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.
FDA Enforcement
Class II
·Completed·GE Healthcare, LLC·December 19, 2018
Discovery NM/CT 670 ES, model 5376204-70-57
FDA Enforcement
Class II
·Completed·GE Healthcare, LLC·December 19, 2018
Revolution CT
FDA Enforcement
Class II
·Completed·GE Healthcare, LLC·July 14, 2021