BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    EchoGo Pro

    K Number: K201555 · Decision Dec 18, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    21
    Applicant Total
    2
    Review Days
    191

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    Basic Information

    Device Name
    EchoGo Pro
    K Number
    K201555
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2060
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ultromics, Ltd.
    Date Received
    June 10, 2020
    Decision Date
    December 18, 2020
    Product Code
    POK
    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
    POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

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    Other Clearances by Ultromics, Ltd.

    K Number Device Name
    K191171 EchoGo Core