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510(k) Data Aggregation

    K Number
    K221592
    Device Name
    AVIEW Lung Nodule CAD
    Manufacturer
    Coreline Soft Co.,Ltd.
    Date Cleared
    2023-02-24

    (267 days)

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

    Coreline Soft Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AVIEW Lung Nodule CAD is a Computer-Aided Detection (CAD) software designed to assist radiologists in the detection of pulmonary nodules (with diameter 3-20 mm) during the review of CT examinations of the chest for asymptomatic populations. AVIEW Lung Nodule CAD provides adjunctive information to alert the radiologists to regions of interest with suspected lung nodules that may otherwise be overlooked. AVIEW Lung Nodule CAD may be used as a second reader after the radiologist has completed their initial read. The algorithm has been validated using non-contrast CT images, the majority of which were acquired on Siemens SOMATOM CT series scanners; therefore, limiting device use to use with Siemens SOMATOM CT series is recommended.
    Device Description
    The AVIEW Lung Nodule CAD is a software product that detects nodules in the lung. The lung nodule detection model was trained by Deep Convolution Network (CNN) based algorithm from the chest CT image. Automatic detection of lung nodules of 3 to 20mm in chest CT images. By complying with DICOM standards, this product can be linked with the Picture Archiving and Communication System (PACS) and provides a separate user interface to provide functions such as analyzing, identifying, storing, and transmitting quantified values related to lung nodules. The CAD's results could be displayed after the user's first read, and the user could select or de-select the mark provided by the CAD. The device's performance was validated with SIEMENS’ SOMATOM series manufacturing. The device is intended to be used with a cleared AVIEW platform.
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    K Number
    K214036
    Device Name
    AVIEW
    Manufacturer
    Coreline Soft Co.,Ltd.
    Date Cleared
    2022-12-23

    (365 days)

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

    Coreline Soft Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AVIEW provides CT values for pulmonary tissue from CT thoracic and cardiac datasets. This software can be used to support the physician providing quantitative analysis of CT images by image segmentation of sub-structures in the lung, lobe, airways, fissures completeness, cardiac, density evaluation, and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data set on-premises and as a cloud environment to allow users to connect by various environments such as mobile devices and Chrome browsers. Converts the sharp kernel for quantitative analysis of segmenting low attenuation areas of the lung. Characterizing nodules in the lung in a single study or over the time course of several thoracic studies. Characterizations include type, location of the nodule, and measurements such as size (major axis, minor axis), estimated effective diameter from the volume of the nodule, the volume of the nodule, Mean HU(the average value of the CT pixel inside the nodule in HU), Minimum HU, Max HU, mass (mass calculated from the CT pixel value), and volumetric measures(Solid major, length of the longest diameter measure in 3D for a solid portion of the nodule, Solid 2nd Major: The size of the solid part, measured in sections perpendicular to the Major axis of the solid portion of the nodule), VDT (Volume doubling time), and Lung-RADS (classification proposed to aid with findings.) ). The system automatically performs the measurement, allowing lung nodules and measurements to be displayed and, integrate with FDA certified Mevis CAD (Computer aided detection) (K043617). It also provides the Agatston score, and mass score by the whole and each artery by segmenting four main arteries (right coronary artery, left main coronary, left anterior descending, and left circumflex artery). Based on the calcium score provides CAC risk based on age and gender. The device is indicated for adult patients only.
    Device Description
    The AVIEW is a software product that can be installed on a PC. It shows images taken with the interface from various storage devices using DICOM 3.0, the digital image and communication standard in medicine. It also offers functions such as reading, manipulation, analyzing, post-processing, saving, and sending images by using software tools. And is intended for use as a quantitative analysis of CT scanning. It provides the following features such as segmentation of lung, lobe, airway, fissure completeness, semi-automatic nodule management, maximal plane measures and volumetric measures, automatic nodule detection by integration with 3rd party CAD. It also provides the Brocks model, which calculates the malignancy score based on numerical or Boolean inputs. Follow-up support with automated nodule matching and automatically categorize Lung-RADS score, which is a quality assurance tool designed to standardize lung cancer screening CT reporting and management recommendations that are based on type, size, size, size, size, size, size, size, size, size, size change, and other findings that are reported. It also provides a calcium score by automatically analyzing coronary arteries from the segmented arteries
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