Vital, Vitrea fX and Vitrea Enterprise Suite fX

  • Modèle / numéro de série
    none
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including states of: AL, AZ, AR, CA, CO, FL, GA, IA, KY, LA, MD, MA, MI, MN, MO, MT, NY, NJ, ND, OH, PA, PR, TN, TX, WA, WI, and WY, and countries of: CANADA, NETHERLANDS, TAIWAN, CHINA, SINGAPORE, UNITED KINGDOM, BRAZIL, GERMANY, RUSSIA, THAILAND, FRANCE, REPUBLIC OF KOREA, SPAIN, PAKISTAN,IRELAND, JAPAN, AUSTRALIA, INDIA, CZECH REPUBLIC, HONG KONG, EGYPT, ITALY, AUSTRIA, SLOVAK IA, BULGARIA, LEBANON, ALGERA, TAIWAN, SOUTH ARICA, BELGIUM, MALAYSIA, DENMARK, and JORDAN.CANADA, NETHERLANDS, TAIWAN, CHINA, SINGAPORE, UNITED KINGDOM, BRAZIL, GERMANY, RUSSIA, THAILAND, FRANCE, REPUBLIC OF KOREA, SPAIN, PAKISTAN,IRELAND, JAPAN, AUSTRALIA, INDIA, CZECH REPUBLIC, HONG KONG, EGYPT, ITALY, AUSTRIA, SLOVAK IA, BULGARIA, LEBANON, ALGERA, TAIWAN, SOUTH ARICA, BELGIUM, MALAYSIA, DENMARK, JORDAN.
  • Description du dispositif
    Vital, Vitrea fX and Vitrea Enterprise Suite fX || Model number: Vitrea fX 2.1, fX 3.0, and fX 3.1 || Vitrea Enterprise Suite (VES) fX 1.2 and VES fX 1.3 || The Vitrea 4D CT Brain Perfusion option is intended for post processing based on dynamic CT images continuously acquired during the infection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion-related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Vital Images, Inc., 5850 Opus Parkway Suite 300, Plymouth MN 55343-4414
  • Société-mère du fabricant (2017)
  • Source
    USFDA