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510(k) Data Aggregation

    K Number
    K232928
    Device Name
    DeepContour (V1.0)
    Manufacturer
    Wisdom Technologies., Inc.
    Date Cleared
    2024-05-07

    (230 days)

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

    Wisdom Technologies., Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DeepContour is a deep learning based medical imaging software that allows trained healthcare professionals to use DeepContour as a tool to automatically process CT images. In addition, DeepCoutour is suitable for the following conditions: 1. Creation of contours using deep-learning algorithms , support quantitative analysis, organ HU distribution statistics, transfer contour files to TPS, and create management archives for patients. 2. Analvze the anatomical structure at different anatomical positions. 3. Rigid and elastic registration based on CT. 4. 3D reconstruction, editing and other visual tools based on organ contours
    Device Description
    DeepContour is a deep learning based medical imaging software that allows trained healthcare professionals to use DeepContour as a tool to automatically process CT images. DeepContour contouring workflow supports CT input data and produces RTSTRUCT outputs. The organ segmentation can also be combined into templates, which can be customized by different hospitals according to their needs. DeepContour provides an interactive contouring application to edit and review the contours automatically generated by DeepContour.
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    K Number
    K231273
    Device Name
    ArcherQA (V1.0)
    Manufacturer
    Wisdom Technologies., Inc.
    Date Cleared
    2024-01-05

    (248 days)

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

    Wisdom Technologies., Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ArcherQA is a software product intended to provide quality assurance of a radiation treatment plan generated by a commercial treatment planning system (TPS) by allowing a clinician to re-calculate dose parameters with dose calculation algorithms independent from the commercial TPS and compare the two set of dose information. ArcherQA is not a TPS or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
    Device Description
    ArcherQA (v1.0) is a standalone software product used within a radiation therapy clinic for quality assurance ( Q A ) and treatment plan verification via recalculation of the dose with a GPU-based independent Monte Carlo dose calculation algorithm. ArcherQA is neither a radiation delivery device (e.g. a linear accelerator) nor a Treatment Planning System (TPS). ArcherQA cannot design or transmit instructions to a delivery device or control any other medical device. ArcherQA is an analysis tool meant solely for QA purposes when used by trained medical professionals. Being a software-only QA tool, ArcherQA never comes into contact with patients. ArcherQA performs dose calculation verifications for radiation treatment plans by independently calculating radiation dose. Using both algorithm and hardware-enhanced Monte Carlo methods, ArcherQA can verify the final dose for radiotherapy plans. The calculation is based on read-in treatment plans that are initially calculated by a TPS. ArcherQA supports photon and electron dose calculation. The treatment modalities that can be evaluated by ArcherQA include: three-dimensional conformal radiotherapy (3D CRT), intensity-modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT), stereotactic radiosurgery (SRS), stereotactic body radiotherapy (SBRT). ArcherQA also performs dose delivery OA by using the measurement data recorded in a linear accelerator's delivery log files to compare with calculated the delivery dose. This is presented to the end user in a software component of ArcherQA called Fraction Check.
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