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

    STarFix Designer Software C0265

    K Number: K231141 · Decision Sep 8, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    12
    Review Days
    140

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    Basic Information

    Device Name
    STarFix Designer Software C0265
    K Number
    K231141
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    FHC, Inc.
    Date Received
    April 21, 2023
    Decision Date
    September 8, 2023
    Product Code
    QRI
    Advisory Committee
    Neurology
    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
    QRI Surgical Planning Software For Neurological Stereotaxic Instruments

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