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510(k) Data Aggregation

    K Number
    K180289
    Device Name
    3D Bolus Software
    Manufacturer
    Date Cleared
    2018-07-10

    (159 days)

    Product Code
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    3D Bolus, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    3D Bolus Software is indicated for, and intended for use as, an accessory to a radiation therapy treatment planning system (TPS) to design patient-specific 3D-printable objects intended for use during external beam photon or electron radiation therapy, or brachytherapy.
    Device Description
    The 3D Bolus Software is a device consisting of software that is used in conjunction with a radiation therapy treatment planning system (TPS) to produce a software file that can be used with a 3D printer to produce a customized, patient-specific bolus for electron or photon external beam radiation therapy or a customized, patient-specific surface brachytherapy mold. A radiation therapy bolus is used when treating uneven surface areas of a patient, such as at the nose or ears, to make up for missing tissue, or to provide build-up of dose to the skin surface. The use of a 3D printed bolus in postmastectomy radiation therapy has been proven to not only improve fit of the bolus, but also reduces patient setup time by approximately 30% compared with standard vinyl gel sheet bolus, according to an intra-patient study comparing both methods. Additionally, the 3D Bolus Software designed bolus can modulate electron beam radiation therapy to produce a conformal high dose region around the tumor. Files for three types of structures can be generated by the 3D Bolus Software and checked by the user on their TPS for correctness. When accepted by the user, the 3D Bolus Software will create a Stereolithography (STL) file for the user to print on a thirdparty 3D printer located within the facility.
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