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510(k) Data Aggregation

    K Number
    K242994
    Device Name
    OncoStudio (OS-01)
    Manufacturer
    OncoSoft. Co., Ltd.
    Date Cleared
    2025-02-24

    (151 days)

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

    OncoSoft. Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OncoStudio provides deep-learning-based automatic contouring to organs at risk in DICOM-RT format from CT images. This software could be used as an initial contouring for the clinicians to be confirmed by the radiation oncology department for treatment planning or other professions where a segmented mask of organs is needed. - Deep learning contouring from Head & Neck, Thorax, Abdomen, and Pelvis - Generates DICOM-RT structure of contoured objects - Manual Contouring - Receive, transmit, store, retrieve, display, and process medical images and DICOM objects
    Device Description
    OncoStudio is a standalone software that provides deep-learning-based automatic contouring to organs at risk in DICOM-RT format from CT images. This software could be used as an initial contouring for the clinicians to be confirmed by the radiation oncology department for treatment planning or other professions where a segmented mask of organs is needed. - Deep learning contouring from Head & Neck, Thorax, Abdomen, and Pelvis - Generates DICOM-RT structure of contoured objects - Manual Contouring - Receive, transmit, store, retrieve, display, and process medical images and DICOM objects It also has the following general functions: - Patient management; - Review of processed images; - Open and Save of files.
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