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510(k) Data Aggregation

    K Number
    K133937
    Device Name
    HEARTSCAN SOFTWARE
    Manufacturer
    MORPHEUS IMAGING, INC
    Date Cleared
    2014-03-03

    (70 days)

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

    MORPHEUS IMAGING, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HeartScan consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartScan specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. It provides clinically relevant and reproducible, quantitative data and has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by HeartScan is intended to be used to support qualified cardiologist, radiologist or other licensed professional healthcare practitioners for clinical decision making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.
    Device Description
    Morpheus HeartScan is a web-accessible image analysis software application. The application is intended to visualize and quantify cardiac-specific MRI data in DICOM format. HeartScan has features for loading, saving, generating screen displays, and aggregating flow statistics. Pre-existing MR images are uploaded via the web to the HeartScan software application where image corrections (specific to aliasing errors) are applied to the set of images prescribed by the user. Automatic or manual vessel segmentation is performed and advanced analysis algorithms are applied to quantify blood flow. The images and blood flow can be simultaneously visualized at any plane using multi-planar reconstruction (MPR) with color flow fusion. Reproducible test results are produced and stored in the image study. HeartScan does not interface directly with any MR or data collection equipment, instead HeartScan imports data files previously generated by such equipment. The software application applied advanced automated methods to avoid tedious, time-consuming manual methods. The software does not perform any functions which cannot be accomplished by a trained user utilizing manual tracing methods; the purpose of the software is to save time and automate potential error-prone manual tasks.
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