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510(k) Data Aggregation

    K Number
    K230221
    Device Name
    QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)
    Manufacturer
    Versant Medical Physics and Radiation Safety
    Date Cleared
    2023-08-28

    (214 days)

    Product Code
    IYX
    Regulation Number
    892.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Versant Medical Physics and Radiation Safety

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QDOSE® Multi-purpose Voxel Dosimetry is indicated for use to provide estimates of radiation absorbed dose to organs and tissues of the body from medically administered radiopharmaceuticals, and to calculate total-body effective dose. Radiation absorbed dose calculations are based on clinical measurements of radioactivity biodistributions and biokinetics. QDOSE® is intended for applications in clinical nuclear medicine, molecular radiotherapy, radiation safety evaluations, risk assessment, record-keeping, and regulatory compliance. QDOSE® is indicated for use by professionals (medical physicists, radiologists and oncologists including nuclear medicine physicians), radiologic imaging technologists, health physicists and radiation safety officers and administrators, students in training, and others having interest in ability to calculate internal radiation doses from medically administered radiopharmaceuticals.
    Device Description
    QDOSE® is a software package for calculating internal radiation doses from clinically administered radiopharmaceuticals. Patient time-activity data may be imported to QDOSE® in DICOM files from nuclear medicine clinical imaging. Dosimetry performed within QDOSE® is based on the use of calculated S values, determined for patient-like phantoms using a Monte Carlo method. The S values provide the average absorbed dose to a target organ generated by a unit of activity in a source organ time-activity curves from quantitative nuclear medicine imaging data are integrated to yield an estimate of the number of radionuclide decays representing the area under a time-activity function, similarly to the mathematical process used by OLINDA/EXM. QDOSE® dose calculations are performed by multiplying a source organ timeactivity curve integral by the S value generated from Monte Carlo calculations. The product of the dose calculations is an output of radiation absorbed doses to specified target organs per unit administered activity.
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