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510(k) Data Aggregation

    K Number
    K083423
    Device Name
    COLONCAD API 3.1
    Manufacturer
    MEDICSIGHT PLC
    Date Cleared
    2011-05-17

    (909 days)

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

    MEDICSIGHT PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medicsight ColonCAD™ API is a non-invasive computer aided detection (CAD) image analysis software tool designed to assist radiologists in the detection of colorectal polyps during their review of digital images derived from CT colonography (CTC). This CAD software post-processes the CTC image data obtained from multi-detector computed tomography (MDCT) scanners. The device is intended to be used on patients referred for a CT Colonography examination, as an overlay tool to prompt the radiologist to colonic findings that have been identified by the device. The CAD can assist radiologists after they have made an initial review of all the CTC image data, supporting their evaluation ("second read").
    Device Description
    Medicsight ColonCAD API is a medical imaging software tool designed to assist radiologists in the detection of polyps in CT scans of the product is packaged as an Application Programming Interface (API) which allows it to be integrated into existing medical imaging solutions. The ColonCAD API assists the radiologist in detecting colorectal polyps using mathematical image processing techniques. The CAD assists the radiologist by highlighting potential polyps in 2D and 3D image views. The results are displayed in the form of "CAD marks" on or near the potential polyps. The radiologist must assess every CT scan image to search for polyps and review the CAD marked images to determine if the indicated findings are polyps. Patient management decisions should not be made solely on the results of ColonCAD analysis.
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    K Number
    K042674
    Device Name
    COLON CAR 1.2
    Manufacturer
    MEDICSIGHT
    Date Cleared
    2004-10-19

    (20 days)

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

    MEDICSIGHT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Colon CAR 1.2 is a PC-based, stand-alone, non-invasive, image analysis software application for the display and visualization of 2D and 3D medical image data of the colon derived from CT scans, for the purpose of assisting radiologists and other clinicians in the evaluation of polyps, cancers and other lesions. The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool, or "semi-automatically" through the user selecting single or double seed points followed by interactive fine-tuning the boundaries of the ROI. It also allows for the simultaneous display of supine and prone images. Colon CAR 1.2 contains additional imaging tools which allow enhancement of specified features, and which the clinician can view simultaneously with the non-enhanced view.
    Device Description
    Colon CAR™ (Computer Assisted Reader) 1.2 is a software tool designed to assist radiologists and other clinicians in the evaluation of polyps and other lesions in the colon. The software allows the user to select regions of interest either manually or by selecting a single or double seed point, followed by semi-automatic detection of the ROI boundary. It provides 2D and 3D visualisation of polyps and measurement of polyp characteristics such as size and volume. The further feature of Colon CAR™ 1.2 as compared to the cleared device is a Polyp Enhanced Viewing Filter (PEV), the results of which are presented in a Joint Reader filter view (enhanced and non-enhanced data viewed simultaneously). The PEV filter identifies intra-colonic filling defects protruding into the colonic lumen, thereby highlighting potential polyp candidates for further interrogation by the reporting radiologist. This filter is fully adjustable and, in deciding the desired characteristics of the objects to be highlighted, the radiologist may specify the degree of object sphericity (or roundness), the height of the protruding object in relation to its base (object 'flatness') as well as select an approximate object diameter range.
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    K Number
    K041807
    Device Name
    LUNG CAR 1.1
    Manufacturer
    MEDICSIGHT
    Date Cleared
    2004-07-22

    (16 days)

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

    MEDICSIGHT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lung CAR I.1 is a PC-based, stand-alone, non-invasive, image analysis software application for the display and visualization of 2D and 3D medical image data of the lung derived from CT scans, for the purpose of assisting radiologists and other clinicians in the evaluation of lung lesions (e.g. nodules). The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool, or "semi-automatically" through the user selecting either a single or double seed point followed by interactive fine-tuning the boundaries of the ROI. Lung CAR 1.1 provides quantative information for measurement of lesion volume and other measured characteristics over time allowing the user to review and track any changes in the physician-indicated nodules or lesions. Lung CAR 1.1 contains additional imaging tools which allow enhancement of specified features, and which the clinician can view simultaneously with the nonenhanced view.
    Device Description
    Lung CAR™ (Computer Assisted Reader) 1.1 is a software tool designed to assist radiologists and other clinicians in the evaluation of nodules and other lesions in the lug. The software allows the user to select Regions of Interest either manually or by selecting a single or double seed point, followed by semi-automatic detection of the ROI boundary. It provides 2D and 3D visualisation of nodules and other lesions, and measurement of nodule characteristics such as size and volume. The further features of Lung CAR™ 1.1 as compared to the cleared device are a series of filters, the results of which are presented in a Joint Reader filter view (enhanced and non-enhanced data viewed simultaneously). These filters are an edge enhancement filter, noise removal filters and a sphericity filter. The sphericity filter enhances structures of images with spherical elements within certain Hounsfield Unit (HU) ranges that are defined by the user. This enhancement can aid the user when looking at a highlighted area (sphere) as a potential spherical nodule.
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    K Number
    K033412
    Device Name
    MEDICLUNG, RELEASE 1
    Manufacturer
    MEDICSIGHT
    Date Cleared
    2003-12-30

    (64 days)

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

    MEDICSIGHT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MedicLung I is a PC-based, stand-alone, non-invasive, image analysis software application for the display and visualization of 2D and 3D medical image data of the lung derived from CT scans, for the purpose of assisting radiologists and other clinicians in the evaluation of lung lesions (e.g. nodules). The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool, or "semiautomatically" through the user selecting either a single or double seed point followed by interactive fine-tuning the boundaries of the ROI. MedicLunq I provides quantative information for measurement of lesion volume and other measured characteristics over time allowing the user to review and track any changes in the physician-indicated nodules or lesions.
    Device Description
    MedicLung™ 1 is a software tool designed to assist radiologists and other clinicians in the evaluation of nodules and other lesions in the lug. The software allows the user to select Regions of Interest either manually or by selecting a single or double seed point, followed by semi-automatic detection of the ROI boundary. It provides 2D and 3D visualisation of nodules and other lesions, and measurement of nodule characteristics such as size and volume.
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    K Number
    K032823
    Device Name
    MEDICHEART, MODEL RELEASE 1
    Manufacturer
    MEDICSIGHT
    Date Cleared
    2003-11-10

    (61 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICSIGHT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MedicHeart 1 is a PC-based, stand-alone, non-invasive, image analysis software application intended to assist radiologists and other clinicians in the identification and quantification of coronary calcified plaques in the coronary arteries from CT image data. This quantification allows for evaluation of the progression or regression of calcified plaques in coronary arteries over time.
    Device Description
    MedicHeart™ is a software tool designed to assist radiologists and other clinicians in the identification and quantification of coronary artery calcification. The software allows the user to manually select Regions of Interest by a single click or a drawing tool followed by semi-automatic detection. It provides calculation of calcium score using the traditional Agatston method, as well as measurement of the volume and mass of calcified plaques.
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    K Number
    K033102
    Device Name
    MEDIC COLON MODEL, RELEASE 1
    Manufacturer
    MEDICSIGHT
    Date Cleared
    2003-11-05

    (37 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICSIGHT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MedicColon I is a PC-based, stand-alone, non-invasive, image analysis software application for the display and visualization of 2D and 3D medical image data of the colon derived from CT scans, for the purpose of assisting radiologists and other clinicians in the evaluation of polyps, cancers and other lesions. The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool, or "semi-automatically" through the user selecting a seed point followed by interactive fine-tuning the boundaries of the ROI. It also allows for the simultaneous display of supine and prone images
    Device Description
    MedicColon™ 1 is a software tool designed to assist radiologists and other clinicians in the evaluation of polyps, cancers and other lesions in the colon. The software allows the user to select Regions of Interest either manually or by selecting a single or double seed point, followed by semi-automatic detection of the ROI boundary. It provides 2D and 3D visualisation of polyps and other lesions, and measurement of polyp characteristics such as size and volume.
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