Device Recall Focal Radiation Treatment Planning Workstation

  • 모델명 / 제조번호(시리얼번호)
    Release 4.51.00 and higher
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Algeria, Australia, Belarus, Belgium, Brazil, Canada, Chile, China, Egypt, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Latvia, Libya, Lithuania, Mexico, Morocco, Netherlands, New Zealand, Philippines, Poland, Romania, Singapore, Slovenia, South Africa, Spain, Suriname, Switzerland, Taiwan, Turkey, Turkmenistan, and the United Kingdom.
  • 제품 설명
    Focal Radiation Treatment Planning Workstation. Focal Release 4.51.00 and above. || Allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data form a Windows-based PC and transfer the information back to the RTP system. It is intended for use in radiation treatment planning using generally accepted contouring methods.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Computerized Medical Systems Inc, 13723 Riverport Drive, Suite 100, Maryland Heights MO 63043
  • 제조사 모회사 (2017)
  • Source
    USFDA