Device Recall Soma v Automated Breast Ultrasound System

  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: H1280099, H1180094, B1380105
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Distributed in California and Illinois.
  • 제품 설명
    Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. || Indicated as an adjunct to mammography for breast cancer screening.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    U-systems Inc, 447 Indio Way, Sunnyvale CA 94085-4203
  • Source
    USFDA