Device Recall CyberKnife Robotic Radiosurgery System Device

  • 모델명 / 제조번호(시리얼번호)
    Item Number : 025000. Serial Number: C0150. Model numbers: Multi Plan Treatment Planning System, Software version 3.0, 3.1, 3.50, and 3.5.1.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA and countries including: Canada, Turkey, India, Russia, Italy, France, Belgium, Netherlands the UK, Spain, Athens, Saudi Arabia, Switzerland, the Ukraine, Germany, Korea and Hong Kong.
  • 제품 설명
    Radiation therapy device. Medical charged particle radiation therapy system with software version. Model Numbers: Multi Plan Treatment Planning System, Software version 3.0, 3.1, 3.5.0, and 3.5.1. || For the treatment planning and image guided radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Accuray Inc, 1310 Chesapeake Ter, Sunnyvale CA 94089-1100
  • Source
    USFDA