Regulatory & Compliance

Documents & Certifications

Cercare Medical is ISO 27001 Certified

Clearance

CE
All devices are CE-marked according to
the European Medical Device Regulation
2017/745.
FDA CLEARED
Select devices are FDA cleared – not all maps/features are available in the US. For detailed regulatory status of Cercare Medical devices in the US or other countries,
please consult the product overview or contact us.

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    Imaging

    MTT

    SVD model

    MTT

    Vascular Model

    T2 FLAIR

    follow-up image
    Perfusion maps of a stroke patient show a large difference in lesion appearance compared to the SVD technique, where the VM appears in better correspondence with the T2 FLAIR follow-up.

    MTT

    SVD model

    MTT

    Vascular Model

    T2 FLAIR

    follow-up image
    The modest degree of tissue involvement is consistent with the
    moderate neurologic deficits, National Institutes of Health Stroke
    Scale (NIHSS) = 4.

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