Device Recall Hitachi Scenaria CT System Software

  • Modèle / numéro de série
    Serial #'s S5001 - S5011
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution to the following states of: MD, MI, MX, ND, NY, OH and TX.
  • Description du dispositif
    Hitachi Scenaria CT System Software || Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the Scenaria can be post processed by the Scenaria to provide additional information. Post processing capabilities included in the Scenaria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087
  • Société-mère du fabricant (2017)
  • Source
    USFDA