Fluoroscan Mini Carm InSight, software versions 1.x, 2.x, 3.x

  • Model / Serial
    Serial numbers per recall strategy.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x || 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

Manufacturer

  • Manufacturer Address
    Hologic, Inc., 35 Crosby Dr, Bedford MA 01730-1450
  • Manufacturer Parent Company (2017)
  • Source
    USFDA