Devices

Device Recall Optovue iVue with Normative Database

  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed Nationwide and in Canada.
  • Description du dispositif
    Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. || Intended for in vivo imaging.
  • Manufacturer
    Optovue, Inc.
  • 1 Event

Fabricant

Optovue, Inc.
  • Adresse du fabricant
    Optovue, Inc., 2800 Bayview Dr, Fremont CA 94538-6518
  • Société-mère du fabricant (2017)
    Optovue Inc.
  • Source
    USFDA