Device Recall INTIO Inc. ClearStartSVM

  • 모델명 / 제조번호(시리얼번호)
    INTIO Inc. Part #: UM-06-20-0003 for SVM User's Manual
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including MN, FL, PA, WI, NY, and RI.
  • 제품 설명
    INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient assessment using CT (computed tomography) images, in order to plan potential therapies or monitor tumor response to treatment.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Intio Inc, 325 Interlocken Pkwy, Broomfield CO 80021-3497
  • 제조사 모회사 (2017)
  • Source
    USFDA