BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    SICAT Implant V2.0

    K Number: K192348 · Decision Dec 4, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    599
    Registration Numbers
    599
    Same Product Code
    2271
    Applicant Total
    9
    Review Days
    97

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    Basic Information

    Device Name
    SICAT Implant V2.0
    K Number
    K192348
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sicat GmbH & Co. KG
    Date Received
    August 29, 2019
    Decision Date
    December 4, 2019
    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 Sicat GmbH & Co. KG

    K Number Device Name
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    K143655 SICAT OPTIMOTION
    K133320 SICAT FUNCTION
    K103723 SICAT IMPLANT V1.2
    K093090 GALILEOS IMPLANT, VERSION 1.7
    K090119 SICAT IMPLANT
    K061472 GALILEOS IMPLANT, V 1.0