Device Recall Model DMLC IVErgo, Dynamic Multileaf Collimator

  • 모델명 / 제조번호(시리얼번호)
    Identifier : 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116063, 116068, 116013, 116046
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution in the states of CT, FL, GA, IA, MO, NY, ND, OK, RI, TX, VA, WA
  • 제품 설명
    DMLC IV-ERGO || Product Usage: || Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Elekta, Inc., 400 Perimeter Center Ter Ne, Ste 50, Atlanta GA 30346-1227
  • 제조사 모회사 (2017)
  • Source
    USFDA