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

    Ricoh 3D for Healthcare Bolus

    K Number: K253025 · Decision Apr 6, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    50
    Applicant Total
    1
    Review Days
    199

    Basic Information

    Device Name
    Ricoh 3D for Healthcare Bolus
    K Number
    K253025
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ricoh 3D For Healthcare, LLC
    Date Received
    September 19, 2025
    Decision Date
    April 6, 2026
    Product Code
    IXI
    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
    IXI Block, Beam-Shaping, Radiation Therapy

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