BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    CAAS MR 4D Flow

    K Number: K162376 · Decision Dec 8, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    15
    Review Days
    106

    Basic Information

    Device Name
    CAAS MR 4D Flow
    K Number
    K162376
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    PIE MEDICAL IMAGING B.V.
    Date Received
    August 24, 2016
    Decision Date
    December 8, 2016
    Product Code
    LLZ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LLZ System, Image Processing, Radiological

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