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510(k) Data Aggregation

    K Number
    K120076
    Device Name
    RESOLUTIONMD WEB
    Manufacturer
    CALGARY SCIENTIFIC, INC.
    Date Cleared
    2012-04-19

    (100 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RESOLUTIONMD WEB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ResolutionMD(TM) is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.

    The ResolutionMD software is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It is the user's responsibility to ensure that the software is installed on appropriate hardware and that image quality is suitable for the clinical application. Calgary Scientific recommends that users of the ResolutionMD software consult the appropriate American College of Radiology Practice Guidelines pertaining to the anatomy and pathology being studied.

    ResolutionMD Web 2.9 is not to be used for mammography.

    Calcium Scoring module: The ResolutionMD device incorporates a Calcium Scoring module which is used to identify and quantify calcified plaque within the coronary arteries. This protocol is performed on non-contrast enhanced cardiac CT data sets.

    Coronary Analysis module: The ResolutionMD device incorporates a Coronary Analysis protocol which is used to visually identify and measure stenoses in the coronary arteries. This protocol is performed on contrast-enhanced cardiac CTA data sets.

    Vessel Analysis module: ResolutionMD Web 2.9 incorporates a Vessel Analysis module which is used as a postprocessing diagnostic review and analysis application for images viewed from ResolutionMD™, a PACS workstation or DICOM image viewer. It is a tool for use by trained professionals such as physicians, technologists and surgeons to review, edit, analyze and report findings of vascular anatomy. Clinicians can semi-automatically determine contrasted lumen boundaries and stenosis measurements, and evaluate maximum and minimum lumen diameters and length measurements.

    Device Description

    The ResolutionMD(TM) is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the ResolutionMD Web 2.9 PACS system and its various modules (Calcium Scoring, Coronary Analysis, Vessel Analysis), outlining its intended use and regulatory classification. It does not include details on performance metrics, sample sizes, expert qualifications, or study methodologies.

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