Devices

Hologic Delphi

  • Model / Serial
    S/N: 70638A 70756 70387C 71202W, and  70089W.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Europe, Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Great Britain, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Macedonia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, Uzbekistan, Algeria, Arab Emirates, Argentina, Australia, Bahrain, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Hong Kong, Indonesia, India, Iran, Iraq, Israel, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Malaysia, Morocco, Mexico, Pakistan, Peru, Puerto Rico, South Africa, Saudia Arabia, Singapore, Syria, Taiwan, Thailand, Tunisia, Venezuela, and Vietnam.
  • Product Description
    Hologic Delphi series Bone Densitometer || Software versions 12.6, 2.3., or 2.4 || Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.
  • Manufacturer
    Hologic, Inc.
  • 1 Event

Manufacturer

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

One device with a similar name

Learn more about the data here

Device Recall Hologic Delphi Bone Densitometers
  • Model / Serial
    S/N: 70411W 70456W 71132C 71132C 71205W 70007C 70024C 70102C 70129C 70138C 70351C 70379A 70394A 70395C 70414A 70415A 70418A 70419A 70421A 70434W 70512A 70525W 70545W 70561W 70603W 70609C 70677C 70678W 70717C 70721W 70724A 70734A 70744C 70761C 70791C 70817W 70824C 70845C 70855SL 70896SL 70987W 71016C 71035W 71076C 71091C 71151C 71172SL 71188C 71223C 71231W 71239C 71255W 71257C 71287C 71342C and 71386C
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Canada Algeria, AE, Australia, Belgium,China,France, Germany, Hungary, Hong Kong, Iceland, Iran, Ireland, Israel, Italy,Japan,Korea, Kuwait, Lithuania, Mexico, Myanmar, Netherlands, Pakistan, Peru, Russia, S. Africa, Saudi Arabia, Singapore, Slovak Rep., Switzerland, Syria, Taiwan, UK
  • Product Description
    Hologic Delphi Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.
  • Manufacturer
    Hologic, Inc.