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

    SYNGO. PLAZA VA20A

    K Number: K101666 · Decision Aug 10, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    599
    Registration Numbers
    599
    Same Product Code
    2271
    Applicant Total
    31
    Review Days
    57

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    Basic Information

    Device Name
    SYNGO. PLAZA VA20A
    K Number
    K101666
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens AG Medical Solutions
    Date Received
    June 14, 2010
    Decision Date
    August 10, 2010
    Product Code
    LLZ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    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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