Optovue RTVue, iVue

  • 모델명 / 제조번호(시리얼번호)
    All units of these models.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) and Internationally.
  • 제품 설명
    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

제조사

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