Device Recall DXG Digitizer

  • Modèle / numéro de série
    Model No. 5170/100
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-- USA (nationwide) including the states of AZ, CA, CO, FL, GA, HI, IL, IN, KS, LA, ME, MI, MN, MO, NE, NH, NJ, NY, OH, OK, PA, SD, TX, VA, WA, WI and WV, and Canada.
  • Description du dispositif
    Agfa Computed Radiography Systems with DX-G Digitizer. || DX-G Digitizers haved the same intended use as the predicate devices. they are intended to use in providing diagnostic images to aid the physician with diagnosis. DX-G Digitizers provide the ability to use both standand needle phosphor image plates and can be used with either Musica or Musica 2. In the US, Agfa's Computed Radiography Systems with DX-G Digitizers are not intended for use in mammography.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    AGFA Corp., 10 S Academy St, Greenville SC 29601-2632
  • Source
    USFDA