Fluoroscan Mini Carm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2

  • Modèle / numéro de série
    Serial numbers per recall strategy.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: DE, RU, AU, IT, GB, ES, FR, KR, ZA, CA, AR, LT, TW, CN, BE, AT, JP, QA, SA, SG, HK, SI, NL, and SE.
  • Description du dispositif
    Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 || The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Hologic, Inc., 35 Crosby Dr, Bedford MA 01730-1450
  • Société-mère du fabricant (2017)
  • Source
    USFDA