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510(k) Data Aggregation

    K Number
    K231668
    Device Name
    Spine CAMP™ (1.1)
    Manufacturer
    Medical Metrics, Inc.
    Date Cleared
    2023-07-07

    (30 days)

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

    Medical Metrics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Spine CAMP™ is a fully-automated software that analyzes X-ray images of the spine to produce reports that contain static and/or motion metrics. Spine CAMP™ can be used to obtain metrics from sagittal plane radiographs of the lumbar and/or cervical spine and it can be used to visualize intervertebral motion via an image registration method referred to as "stabilization." The radiographic metrics can be used to characterize and assess spinal health in accordance with established quidance. For example, common clinical uses include assessing spinal stability, alignment, degeneration, fusion, motion preservation, and implant performance. The metrics produced by Spine CAMP are intended to be used to support qualified and licensed professional healthcare practitioners in clinical decision making for skeletally mature patients of age 18 and above.
    Device Description
    Spine CAMP™ is a fully-automated image processing software device. It is designed to be used with X-ray images and is intended to aid medical professionals in the measurement and assessment of spinal parameters. Spine CAMP™ is capable of calculating distances, angles, linear displacements, angular displacements, and mathematical combinations of these metrics to characterize the morphology, alignment, and motion of the spine. These analysis results are presented in the form of reports, annotated images, and visualizations of intervertebral motion to support their interpretation.
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    K Number
    K221632
    Device Name
    Spine CAMP™
    Manufacturer
    Medical Metrics, Inc.
    Date Cleared
    2022-10-18

    (134 days)

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

    Medical Metrics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Spine CAMP™ is a fully-automated software that analyzes X-ray images of the spine to produce reports that contain static and/or motion metrics. Spine CAMP™ can be used to obtain metrics from sagittal plane radiographs of the lumbar and/or cervical spine and it can be used to visualize intervertebral motion via an image registration method referred to as "stabilization". The radiographic metrics can be used to characterize and assess spinal health in accordance with established guidance. For example, common clinical uses include assessing spinal stability, alignment, degeneration, fusion, motion preservation, and implant performance. The metrics produced by Spine CAMP™ are intended to be used to support qualified and licensed professional healthcare practitioners in clinical decision-making for skeletally mature patients of age 18 and above.
    Device Description
    Spine CAMP™ is a fully-automated image processing software device. It is designed to be used with X-ray images and is intended to aid medical professionals in the measurement and assessment of spinal parameters. Spine CAMP™ is capable of calculating distances, angles, linear displacements, angular displacements, and mathematical combinations of these metrics to characterize the morphology, alignment, and motion of the spine. These analysis results are presented in the form of reports, annotated images, and visualizations of intervertebral motion to support their interpretation.
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    K Number
    K022585
    Device Name
    KIMAX QMA
    Manufacturer
    MEDICAL METRICS, INC.
    Date Cleared
    2002-10-11

    (67 days)

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

    MEDICAL METRICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KIMAX QMA™ is a quantitative imaging software application. It is designed for physicians and clinical professions who are interested in the analysis of motion in medical images, particularly in musculoskeletal images. KIMAX QMA™ permits users to review static and dynamic digital images acquired from a variety of radiographic to review static and dynamic argultative assessment of motion in radiographic . Information obout the matiative assessment of motion in radiographic ... Information obout th Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a 'motion analysis' report containing graphics, charts and text.
    Device Description
    KIMAX QMA™ is a quantitative imaging software application.
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    K Number
    K013098
    Device Name
    KIMAX REMOTE VIEWING STATION
    Manufacturer
    MEDICAL METRICS, INC.
    Date Cleared
    2001-12-07

    (81 days)

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

    MEDICAL METRICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KIMAX ™ Remote Viewing Station software and hardware (RVS) are intended to allow physicians to view static or dynamic digital images from radiographic and other medical imaging equipment. The RVS includes a high-performance computer, data storage devices, a high-resolution monitor and software to: 1) accept AVI images or import other image formats; 2) allow physician to quickly locate and display images; 3) adjust contrast and brightness, apply filters to enhance the images, zoom in on selected features of interest, pan to selected areas, and annotate images; 4) print out selected images; and 5) create reports that include text and annotated images. The RVS is intended to be used in the clinical workspace of a practicing physician.
    Device Description
    The KIMAX ™ Remote Viewing Station software and hardware (RVS) includes a high-performance computer, data storage devices, a high-resolution monitor and software.
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    K Number
    K010187
    Device Name
    KIMAX, MODEL 1024
    Manufacturer
    MEDICAL METRICS, INC.
    Date Cleared
    2001-02-14

    (23 days)

    Product Code
    JAA
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL METRICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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