Devices

Device Recall Optovue iVue with Normative Database

  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed Nationwide and in Canada.
  • 제품 설명
    Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. || Intended for in vivo imaging.
  • Manufacturer
    Optovue, Inc.
  • 1 Event

제조사

Optovue, Inc.
  • 제조사 주소
    Optovue, Inc., 2800 Bayview Dr, Fremont CA 94538-6518
  • 제조사 모회사 (2017)
    Optovue Inc.
  • Source
    USFDA