BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CADSTREAM

    K Number: K031779 · Decision Aug 6, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    9
    Review Days
    57

    Basic Information

    Device Name
    CADSTREAM
    K Number
    K031779
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CONFIRMA, INC.
    Date Received
    June 10, 2003
    Decision Date
    August 6, 2003
    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 CONFIRMA, INC.

    K Number Device Name
    K092954 CADSTREAM VERSION 5
    K081556 CADSTREAM, VERSION 5.0
    K071534 CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS
    K060547 ACCESS BREAST COIL 4/SMS
    K052045 ACCESS BREAST COIL
    K043216 CADSTREAM VERSION 4.0
    K041020 CADSTREAM VERSION 3.1
    K013574 ACCENT