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510(k) Data Aggregation

    K Number
    K040782
    Device Name
    N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX
    Manufacturer
    IMAGE ANALYSIS, INC.
    Date Cleared
    2004-07-13

    (109 days)

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

    IMAGE ANALYSIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Calcium scoring of calibrated CT images to provide quantitative measures of calcium content in the coronary arteries and aorta. The software is intended to be used under the supervision of trained physicians to monitor progression of vascular calcium which may be useful in the prognosis of Cardiovascular disease. N-Vivo™ Calcium Score is a calibrated software program for non-invasive identification and quantification of calcified plaques in the coronary arteries and aorta using CT images. The software runs on a standard PC with basic image processing, database and reporting functions. N-Vivo™ may be used to monitor progression of calcium which may be useful in the prognosis of cardiovascular disease.
    Device Description
    A software package operating on a PC which facilitates non-invasive measurements of vascular calcified plaques. The device provides Agaston, Volume and Mass Scores using Phantom Calibrated CT images. The key features include: - Hybrid calibration with external phantom and invivo blood pool reference. . - 사 Plaque definition which include statistical and calibrated thresholds for a calcium mass measurement. - . Artery trace which segments regions of the heart that include the coronary arteries and aorta. - . Automated identification, quantification, and scoring of vascular calcium. - 내 PC workstation with web browser based interface which includes database, Dicom reports, Serial graphs and QA module.
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    K Number
    K031991
    Device Name
    DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS
    Manufacturer
    IMAGE ANALYSIS, INC.
    Date Cleared
    2003-07-30

    (33 days)

    Product Code
    KGI
    Regulation Number
    892.1170
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMAGE ANALYSIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DXAVIEW™ Hip and Spine bone densitometry options are intended to estimate bone mineral content (BMC) and bone mineral density (BMD) in the proximal femur and spine. The BMD may be compared to DXA reference data. T-Scores and Z-Scores are calculated with respect to young normal and age matched reference data, and can be used by the physician in determining fracture risk. The DXAVIEW™ Hip and Spine bone densitometry Options are intended to provide estimates of bone mineral density (BMD) and bone mineral content (BMC) in the proximal femur and spine. Young normal reference data taken from caucasian populations can be used to calculate T-Scores. Age matched normal reference data arc used to calculate Z-Scores. The BMD results, along with the T- and Z-Scores, can be used by physicians in their determination of fracture risk and therapy effectivencss.
    Device Description
    The DXAView" Hip and Spine are software Options to the Image Analysis QCT-3D Plus product, which provides 3D projection measurements similar to conventional DXA. The product Options provide estimates of bone mineral content (BMC) and bone density (BMD) of the proximal femur and spine. BMC is expressed in grams and BMD in g/cm2 of calcium hydroxyapatite. DXAView™ uses phantom calibration by Quantitative Computed Tomography (QCT) on all compatible CT scanners. The computations are preformed on 3D CT volumetric image sets obtained with conventional CT protocols and radiation doses.
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    K Number
    K992246
    Device Name
    QCT BONE MINERAL ANALYSIS SOFTWARE
    Manufacturer
    IMAGE ANALYSIS, INC.
    Date Cleared
    1999-09-03

    (59 days)

    Product Code
    KGI
    Regulation Number
    892.1170
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMAGE ANALYSIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QCT bone densitometry is indicated for patients with suspected loss of bone to identify QCT bone delistionied I is meetar of the highly responsive spinal trabecular bone is indicated for early detection of bone loss. QCT is useful for measuring bone loss or gain with time for monitoring osteoporsis QCT Is useful for mousaning other collect to increased fracture risk by WHO criteria.
    Device Description
    QCT Bone Densitometer (QCT 5000 and QCT 3000)
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