Device Recall OPDScan III Refractive Power/Corneal Analyzer Opthalmic

  • 모델명 / 제조번호(시리얼번호)
    Software versions: 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic || Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. || Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use for Mapping of refractive error distribution of the eye by measurement and analysis of spherical power, cylindrical power, and cylinder axis.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Nidek Inc, 47651 Westinghouse Dr, Fremont CA 94539-7474
  • 제조사 모회사 (2017)
  • Source
    USFDA