BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇬 Singapore

    AVA (Augmented Vascular Analysis)

    K Number: K201369 · Decision Sep 16, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    2
    Review Days
    117

    Basic Information

    Device Name
    AVA (Augmented Vascular Analysis)
    K Number
    K201369
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    See-Mode Technologies Pte. Ltd.
    Date Received
    May 22, 2020
    Decision Date
    September 16, 2020
    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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