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510(k) Data Aggregation

    K Number
    K220630
    Device Name
    TorchTM Software
    Manufacturer
    Voximetry, Incorporated
    Date Cleared
    2022-11-28

    (269 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Voximetry, Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Torch™ software is intended to provide estimates (deterministic) of absorbed radiation dose at the voxel level following internal administration of approved radioactive products. This is dependent on input data regarding biodistribution being supplied to the application. Torch software only allows voxel-based dose calculations. For use with internally administered radioactive products. Torch should not be used to deviate from approved product dosing and administration instructions. Refer to the product's prescribing information for instructions.
    Device Description
    Torch is a software device for use in absorbed dose estimation of FDA approved radiopharmaceuticals. After administration of FDA approved radiopharmaceuticals, Torch provides post-treatment dosimetry evaluation on the voxel level using Monte Carlo techniques to assist the clinician in assessing absorbed dose to normal tissues and tumors. Key functions of the Torch software include image import, image registration, contour propagation, pharmacokinetic modelling, and radiation transport modelling which is accelerated using parallel processing capabilities of Graphics Processing Units (GPUs). A Monte Carlo (MC) radiation transport algorithm is used to calculate absorbed dose with very high dosimetric accuracy. Torch relies on medical images (e.g., positron emission tomography (PET), single photon emission computed tomography (SPECT), or computed tomography (CT)) which consist of a three-dimensional matrix of pixels, called voxels. Medical imaging acquired on the voxel level affords measurement of tissue heterogeneity and nonuniform source distribution of radiopharmaceuticals. Monte Carlo produces dose distributions at the voxel level with high precision.
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