BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇿 New Zealand

    Volpara Imaging Software

    K Number: K211279 · Decision Jul 27, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    2
    Review Days
    91

    Basic Information

    Device Name
    Volpara Imaging Software
    K Number
    K211279
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Volpara Health Technologies Limited
    Date Received
    April 27, 2021
    Decision Date
    July 27, 2021
    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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    Other Clearances by Volpara Health Technologies Limited

    K Number Device Name
    K182310 Volpara Imaging Software