Device Recall nordicICE v 2.3.14

  • 모델명 / 제조번호(시리얼번호)
    Version 2.3.14
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia , Belgium, Brazil, China, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway and Poland.
  • 제품 설명
    nordicICE v 2.3.14 || nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. nordicICE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRI, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    NordicNeuroLab AS, Mollendalsveien 65c, Bergen Norway
  • 제조사 모회사 (2017)
  • Source
    USFDA