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

    Affirm 800

    K Number: K243077 · Decision Jun 27, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    198
    Applicant Total
    2
    Review Days
    270

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    Basic Information

    Device Name
    Affirm 800
    K Number
    K243077
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1600
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
    Date Received
    September 30, 2024
    Decision Date
    June 27, 2025
    Product Code
    IZI
    Advisory Committee
    Radiology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IZI System, X-Ray, Angiographic

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    Other Clearances by Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)

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