Optovue RTVue, iVue

  • Modelo / Serial
    All units of these models.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) and Internationally.
  • Descripción del producto
    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; || The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA || The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Optovue Inc., 2800 Bayview Dr, Fremont CA 94538-6518
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA