Device Recall Optovue RTVue Optical Coherence Tomography with Normative Database

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers from 10005 to 11805 (serial number are sequential)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and Worldwide
  • 제품 설명
    Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions 3.0.x.x and higher, with Normative Database, manufactured by Optovue, Fremont, CA || The RTVue 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., 45331 Northport Loop W, Fremont CA 94538-6417
  • 제조사 모회사 (2017)
  • Source
    USFDA