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510(k) Data Aggregation

    K Number
    K243689
    Device Name
    AVIEW
    Manufacturer
    Coreline Soft Co., Ltd.
    Date Cleared
    2025-03-19

    (110 days)

    Product Code
    QIH, JAK
    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 to soft 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 nodule type, location of the nodule, and measurements such as size (major axis), estimated effective diameter from the volume of 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 Maior: The size of the longest diameter 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 AVIEW Lung Nodule CAD (Computer aided detection) (K221592). It also provides the Agatston score, volume 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, 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 and management recommendations that are based on type, size, size change, and other findings that are reported. It also provides a calcium score by automatically analyzing coronary arteries.
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    K Number
    K243696
    Device Name
    AVIEW CAC
    Manufacturer
    Coreline Soft Co., Ltd.
    Date Cleared
    2025-02-14

    (77 days)

    Product Code
    QIH, JAK
    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 CAC provides quantitative analysis of calcified plaques in the coronary arteries using non-contrast/non-gated Chest CT scans. It enables the calculation of the Agatston score for coronary artery calcification, segmenting and evaluating the right coronary artery and left coronary artery. Also provide risk stratification based on calcium score, gender, and age, offering percentile-based risk categories by established guidelines. Designed for healthcare professionals, including radiologists and cardiologists, AVIEW CAC supports storing, transferring, inquiring, and displaying CT data sets on-premises, facilitating access through mobile devices and Chrome browsers. AVIEW CAC analyzes existing non-contrast/non-gated Chest CT studies that include the heart of adult patients above the age of 40. Also, the device's use should be limited to CT scans acquired on General Electric (GE) or its subsidiaries (e.g., GE Healthcare) equipment. Use of the device with CT scans from other manufacturers has not been validated or recommended.
    Device Description
    The AVIEW CAC 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 also provides a calcium score by automatically analyzing coronary arteries from the segmented arteries.
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    K Number
    K233211
    Device Name
    AVIEW CAC
    Manufacturer
    Coreline Soft Co., Ltd.
    Date Cleared
    2024-03-29

    (183 days)

    Product Code
    QIH, JAK
    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 CAC provides quantitative analysis of calcified plaques in the coronary arteries using non-contrast non-gated Chest CT scans. It enables the calculation of the Agatston score for coronary artery calcification, segmenting and evaluating the right coronary artery and left coronary artery. Also provide risk stratification based on calcium score, gender, and age, offering percentile-based risk categories by established guidelines. Designed for healthcare professionals, including radiologists and cardiologists, AVIEW CAC supports storing, inquiring, and displaying CT data sets on-premises, facilitating access through mobile devices and Chrome browsers. AVIEW CAC analyzes existing noncontrast/non-gated Chest CT studies that include the heart of adult patients above the age of 40. Also, the device's use should be limited to CT scans acquired on General Electric (GE) or its subsidiaries (e.g., GE Healthcare) equipment. Use of the device with CT scans from other manufacturers has not been validated or recommended.
    Device Description
    The AVIEW CAC 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 also provides a calcium score by automatically analyzing coronary arteries from the segmented arteries.
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    K Number
    K201710
    Device Name
    A View LCS
    Manufacturer
    Coreline Soft Co., Ltd.
    Date Cleared
    2020-10-16

    (115 days)

    Product Code
    LLZ, JAK
    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 LCS is intended for the review and analysis and reporting of thoracic CT images for the purpose of characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include nodule type, location of the nodule and measurements such as size (major axis), estimated effective diameter from the volume of 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 measured in 3D for a solid portion of the nodule. Solid 2nd Major: The length of the longest diameter of the solid part, measured in sections perpendicular to the Major axis of the nodule), VDT (Volume doubling time), Lung-RADS (classification proposed to aid with findings) and CAC score and LAA analysis. The system automatically performs the measurement, allowing lung nodules and measurements to be displayed and, also integrate with FDA certified Mevis CAD (Computer-aided detection) (K043617).
    Device Description
    AVIEW LCS is intended for use as diagnostic patient imaging which is intended for the review and analysis of thoracic CT images. Provides following features as semi-automatic nodule measurement (segmentation), maximal plane measure, 3D measure and volumetric measures, automatic nodules detection by integration with 3th party CAD. Also provides cancer risk based on PANCAN risk 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 is based on type, size, size change and other findings that is reported.
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    K Number
    K200714
    Device Name
    AVIEW
    Manufacturer
    Coreline Soft Co., Ltd
    Date Cleared
    2020-08-26

    (161 days)

    Product Code
    LLZ, JAK
    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 could be used to support the physician quantitatively in the diagnosis, follow up evaluation of CT lung tissue images by providing image segmentation of sub-structures in lung, lobe, airways and cardiac, registration and expiration which could analyze quantitative information such as air trapped index, and inspiration/ expiration ratio. And also, volumetric and structure analysis, density evaluation and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data set on premise and as cloud environment as well to allow users to connect by various environment such as mobile devices and chrome browser. Characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include nodule type, location of the nodule and measurements such as size (major axis), estimated effective diameter from the volume of the nodule, 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 measured in 3D for solid portion of the nodule, Solid 2nd Major: The longest diameter 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 CAC analysis by segmentation of four main artery (right coronary artery, left main coronary, left anterior descending and left circumflex artery then extracts calcium on coronary artery to provide Agatston score, volume score and mass score by whole and each segmented artery type. Based on the score, provides CAC risk based on age and gender.
    Device Description
    The AVIEW is a software product which can be installed on a PC. It shows images taken with the interface from various storage devices using DICOM 3.0 which is 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 the software tools. And is intended for use as diagnostic patient imaging which is intended for the review and analysis of CT scanning. Provides following features as semi-automatic nodule management, maximal plane measure, 3D measures and columetric measures, automatic nodule detection by integration with 3rd party CAD. Also provides Brocks model which calculated 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 is based on type, size, size change and other findings that is reported. It also automatically analyzes coronary artery calcification which support user to detect cardiovascular disease in early stage and reduce the burden of medical.
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    K Number
    K193220
    Device Name
    AVIEW LCS
    Manufacturer
    Coreline Soft Co., Ltd
    Date Cleared
    2020-05-05

    (166 days)

    Product Code
    LLZ, JAK
    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 LCS is intended for the review and analysis and reporting of thoracic CT images for the purpose of characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include nodule type, location of the nodule and measurements such as size (major 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 measured in 3D for a solid portion of the nodule. Solid 2nd Major: The length of the longest diameter of the solid part. measured in sections perpendicular to 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, also integrate with FDA certified Mevis CAD (Computer-aided detection) (K043617).
    Device Description
    AVIEW LCS is intended for use as diagnostic patient imaging which is intended for the review and analysis of thoracic CT images. Provides following features as semi-automatic nodule measurement (segmentation), maximal plane measure, 3D measure and volumetric measures, automatic nodules detection by integration with 3th party CAD. Also provides cancer risk based on PANCAN risk 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 is based on type, size, size change and other findings that is reported. - -Nodule measurement - Adding nodule by segmentation or by lines . - Semi-automatic nodule measurement (segmentation) " - . Maximal plane measure, 3D measure and volumetric measure. - . Automatic large vessel removal. - י Provides various features calculated per each nodule such as size, major(longest diameter measured in 2D/3D), minor (shortest diameter measured in 2D/3D), maximal plane, volume, mean HU, minimum HU, maximum HU for solid nodules and ratio of the longest axis for solid to non solid for paritla solid nodules. - . Fully supporting Lung-RADS workflow: US Lung-RADS and KR Lung-RADS. - . Nodule malignancy score (PANCAN model) calculation. - . Importing from CAD results - -Follow-up - ' Automatic retrieving the past data - י Follow-up support with nodule matching and comparison - Automatic calculation of VDT (volume doubling time) - Automatic nodule detection (CADe) - - Seamless integration with Mevis Visia (FDA 510k Cleared) . - -Lungs and lobes segmentation - Better segmentation of lungs and lobes based on deep-learning algorithms. - -Report - PDF report generation . - . It saves or sends the pdf report and captured images in DICOM files. - . It provides structured report including following items such as nodule location and, also input finding on nodules. - Reports are generated using the results of all nodules nodules detected so far (Lung RADS) . - -Save Result - . It saves the results in internal format
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    K Number
    K192040
    Device Name
    AVIEW Modeler
    Manufacturer
    Coreline Soft Co., Ltd
    Date Cleared
    2019-12-20

    (142 days)

    Product Code
    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
    The AVIEW Modeler is intended for use as an image review and segmentation system that operates on DICOM imaging information obtained from a medical scanner. It is also used as a pre-operative software for surgical planning. 3D printed models generated from the output file are for visualization and educational purposes only and not for diagnostic use.
    Device Description
    The AVIEW Modeler is a software product which can be installed on a separate PC, it displays patient medical images on the screen by acquiring it from image Acquisition Device. The image on the screen can be checked edited, saved and received. - -Various displaying functions - Thickness MPR., oblique MPR, shaded volume rendering and shaded surface rendering. - . Hybrid rendering of simultaneous volume-rendering and surface-rendering. - -Provides easy to-use manual and semi-automatic segmentation methods - Brush, paint-bucket, sculpting, thresholding and region growing. " - . Magic cut (based on Randomwalk algorithm) - -Morphological and Boolean operations for mask generation. - Mesh generation and manipulation algorithms. - - Mesh smoothing, cutting, fixing and Boolean operations. - -Exports 3d-printable models in open formats, such as STL. - DICOM 3.0 compliant (C-STORE, C-FIND) -
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    K Number
    K171199
    Device Name
    AVIEW
    Manufacturer
    Coreline Soft Co., Ltd.
    Date Cleared
    2018-10-31

    (555 days)

    Product Code
    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
    A VIEW provides CT values for pulmonary tissue from CT thoracic datasets. This software can be used to support the physician quantitatively in the diagnosis, followup evaluation of CT lung tissue images by providing image segmentation of sub-structures in the left and right lung (e.g., the five lobes and airway), volumetric and structural analysis, density evaluations and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data sets. A VIEW is not meant for primary image Interpretation in mammography.
    Device Description
    The AVIEW is a software product which can be installed on a PC. It shows images taken with the interface from various storage devices using DICOM 3.0 which is 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 the software tools.
    Ask a Question

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