BEUDAMED
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    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

    Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388

    FDA Enforcement
    Class II ·Completed·Invivo Corporation·November 21, 2018

    3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000

    FDA Enforcement
    Class II ·Completed·Philips Ultrasound, Inc.·September 13, 2023