Devices

Device Recall FUJIFILM Digital Mammography System Aspire HD (FDR MS1000) with Biopsy Positioner (FDR1000BPY)

  • Modèle / numéro de série
    26330437 and 17230408
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to: NC and HI.
  • Description du dispositif
    FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) || The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
  • Manufacturer
    Fujifilm Medical Systems U.S.A., Inc.
  • 1 Event

Fabricant

Fujifilm Medical Systems U.S.A., Inc.
  • Adresse du fabricant
    Fujifilm Medical Systems U.S.A., Inc., 419 West Ave, Stamford CT 06902-6343
  • Société-mère du fabricant (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA