Device Recall DynaCad

  • 모델명 / 제조번호(시리얼번호)
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  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Device is software. Customer notification letters recommended that users discontinue use of the Ktrans, Kep, and iAUGC colormaps when assessing studies from a remotely connected DynaCAD client computer. It is further advised that users refrain from using the colormaps and values derived from ADC maps calculated by DynaCAD. ADC maps originating natively from the MRI system should be used as an alternative as these values are unaffected. Firm will provide a v4.0 software update for the affected software versions (v3.4, v3.5) to correct the defect at no charge to the user.
  • 제품 설명
    DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for other MR analyses modules. || Product Usage: || Intended to be used as a post processing software package designed to provide a reliable means for analyzing MR datasets.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Invivo Corporation, 3545 SW 47th Ave, Gainesville FL 32608-7691
  • 제조사 모회사 (2017)
  • Source
    USFDA