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510(k) Data Aggregation

    K Number
    K223834
    Device Name
    AccuCheck
    Date Cleared
    2023-07-20

    (210 days)

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

    Manteia Technologies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AccuCheck is a quality assurance software used for data transfer integrity check, secondary dose calculation with Monte Carlo algorithm, and treatment plan verification in radiotherapy. AccuCheck also provides independent dose verification based on LINAC delivery log after radiotherapy plan execution. AccuCheck is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
    Device Description
    AccuCheck is a quality assurance software used for data transfer integrity check, secondary dose calculation with Monte Carlo algorithm, and treatment plan verification in radiotherapy. AccuCheck also provides independent dose verification based on LINAC delivery log after radiotherapy plan execution. AccuCheck is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes. AccuCheck performs using the TPS Check module to check related parameters in the radiotherapy plan to determine if the plan is executable by the linear accelerator( LINAC). AccuCheck also performs using the Dose Check module to conduct dose calculation verification for radiation treatment plans before radiotherapy by doing an independent calculation of radiation dose using Monte Carlo algorithm. Radiation dose is initially calculated by a Treatment Planning System (TPS). AccuCheck performs using the Transfer Check module to verify the integrity of the treatment plan transmitted from TPS to the LINAC to check if errors occur during the transmission. AccuCheck performs dose delivery quality assurance for radiation treatment plans by using the measured data recorded in a LINAC's delivery log files to reconstruct executed plan and calculate delivered dose. This is achieved through the software module of the Subject Device called Pre-treatment Check and Treatment Check. The difference lies in the usage scenario, where Pre-treatment Check processes the logs of the first execution of the treatment plan in LINAC without a patient actually being treated, while treatment check processes the logs of the second and subsequent execution of the treatment plan in LINAC with a patient actually being treated. AccuCheck cannot be used for log verification, but rather for dose calculation based on logs such as LINAC delivery log data. The reconstruct of the executed plan and calculation of the delivered dose from delivery logs on LINAC machines, including Varian LINAC and Elekta LINAC, are supported by AccuCheck. The product provides with multiple tools to assist the analysis, including dose volume histogram, Gamma analysis, target coverage, Gamma passing rate of each ROI, dose statistics and clinical targets evaluation.
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    K Number
    K223724
    Device Name
    MOZI TPS
    Date Cleared
    2023-07-10

    (209 days)

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

    Manteia Technologies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MOZI Treatment Planning System (MOZI TPS) is used to plan radiotherapy treatments with malignant or benign diseases. MOZI TPS is used to plan external beam irradiation with photon beams.
    Device Description
    The proposed device, MOZI Treatment Planning System (MOZI TPS), is a standalone software which is used to plan radiotherapy treatments (RT) for patients with malignant or benign diseases. Its core functions include image processing, structure delineation, plan design, optimization and evaluation. Other functions include user login, graphical interface, system and patient management. It can provide a platform for completing the related work of the whole RT plan.
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    K Number
    K221706
    Device Name
    AccuContour
    Date Cleared
    2023-03-09

    (269 days)

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

    Manteia Technologies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    It is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.
    Device Description
    The proposed device, AccuContour, is a standalone software which is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation. The product has two image processing functions: - (1) Deep learning contouring: it can automatically contour organs-at-risk, in head and neck, thorax, abdomen and pelvis (for both male and female) areas, - (2) Automatic registration: rigid and deformable registration, and - (3) Manual contouring. It also has the following general functions: - Receive, add/edit/delete, transmit, input/export, medical images and DICOM data; - Patient management; - Review of processed images; - Extension tool; - Plan evaluation and plan comparison; - Dose analysis.
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