Device Recall Seno Advantage 2.2 workstations with software version 22_01 and 22_02

  • 모델명 / 제조번호(시리얼번호)
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  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of CA, FL, GA, MD, NJ, NM, NY, NC, OK, TX and countries of THAILAND, TAIWAN, SWEDEN SPAIN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, PAKISTAN, MEXICO, JAPAN, ITALY,GREECE, FRANCE, COLOMBIA, CHILE, CANADA, BELGIUM, and BAHRAIN.
  • 제품 설명
    GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 || Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Ge Healthcare, Llc, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
  • Source
    USFDA