Device Recall Hitachi SCENARIA CT System

  • 모델명 / 제조번호(시리얼번호)
    Serial #'s: S5002-S5014; S5017-S5038
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : CA, FL, GA, IA, IL, IN, MD, NC, NY, OH, PA, SD, TN, TX & WY., and Internationally to Brazil and Mexico.
  • 제품 설명
    Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087-2371
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Serial #'s S5001 - S5011
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution to the following states of: MD, MI, MX, ND, NY, OH and TX.
  • 제품 설명
    Hitachi Scenaria CT System Software || Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the Scenaria can be post processed by the Scenaria to provide additional information. Post processing capabilities included in the Scenaria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
  • Manufacturer