Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x

  • Modèle / numéro de série
    Software versions 5.0.x and 5.1.x
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including the states of AL, AR, CA, CO, FL, IL, KY, LA, NE, NC, NJ, NY, OH, PA, TN, TX, UT, WA and WV., and the countries of Canada, Denmark, Iran, Italy, Mexico and Taiwan.
  • Description du dispositif
    Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x || The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for use in the same clinical applications as traditional screen-film mammography systems. Mammography images can be interpreted on either hard copy film or soft copy review workstations, cleared for mammography
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Hologic, Inc., 36 Apple Ridge Rd # 37, Danbury CT 06810-7301
  • Société-mère du fabricant (2017)
  • Source
    USFDA