Devices

Device Recall Optovue iVue with Normative Database

  • Modelo / Serial
    iVue software version 3.0 and 3.1 3.1 is international version, only distributed to Canada but not currently installed in any Canadian facilities.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed Nationwide and in Canada.
  • Descripción del producto
    Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. || Intended for in vivo imaging.
  • Manufacturer
    Optovue, Inc.
  • 1 Event

Fabricante

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