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510(k) Data Aggregation

    K Number
    K103565
    Device Name
    MEDVOXEL HEARTPRO SOFTWARE APPLICATION
    Manufacturer
    MEDVOXEL SYSTEMS INC
    Date Cleared
    2011-04-12

    (127 days)

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

    MEDVOXEL SYSTEMS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HeartPro consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartPro specifically analyzes the blood flow to the heart and its major vessels using 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 HeartPro 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
    MedVoxel HeartPro is a web-accessible, self-contained image analysis software application. The application uses cardiac-specific MR scans as a data source for their blood flow analysis computations. Pre-existing MR images are sent from the PACS (or scanner) to the MedVoxel HeartPro software application, image corrections (specific to aliasing errors) are applied to the set of images prescribed by the user, contour are placed and advanced analysis algorithms are applied. Easily reproducible test results are produced and stored in the Measurement Record of the patients' study. HeartPro does not interface directly with any MR or data collection equipment; instead HeartPro imports data files previously generated by such equipment. HeartPro provides quantitative measurements specific to blood flow analysis for MRI data sequences. The software application focuses on what is visible to the eye and applies 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 intent of the software is to save time and automate potential error-prone manual tasks. The software has functions for loading, analysing, saving datasets and will generate screen displays, computation and aggregated statistics.
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