Device Recall Scanner, Computed Tomography, XRay

  • Modèle / numéro de série
    Serial Number Range (last 4): (2665-3149), (2211-2237), (2057-2067), A3622041, A4582122 + (2690-3131), (2001-2171), (2001-2124), (2001-2255), (2001-3007), (2015-2061), (2001-2008).  The following Device Name/Model Number: Asteion Super 4 / TSX-021B Aquilion Super 4 / TSX-101A/7 Aquilion 8 / TSX-101A/F Aqui1ion 16/ TSX-101A/6 Aqui1ion 16/ TSX-101A/G Aquilion 32 / TSX-101A/D Aquilion 32 / TSX-101A/I Aquilion 64/TSX-101A/E Aquilion 64 / TSX-101AIH Aquilion 16 LB / TSX-201A AquilionONE / TSX-301A
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA ( Nationwide Distribution )
  • Description du dispositif
    Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received an improved table by an upgrade purchase. || This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstruction!;, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the marketplace.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92780-7047
  • Société-mère du fabricant (2017)
  • Source
    USFDA