Devices

Device Recall Soma v Automated Breast Ultrasound System

  • Modèle / numéro de série
    Serial numbers: H1280099, H1180094, B1380105
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in California and Illinois.
  • Description du dispositif
    Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. || Indicated as an adjunct to mammography for breast cancer screening.
  • Manufacturer
    U-systems Inc
  • 1 Event

Fabricant

U-systems Inc
  • Adresse du fabricant
    U-systems Inc, 447 Indio Way, Sunnyvale CA 94085-4203
  • Source
    USFDA