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510(k) Data Aggregation

    K Number
    K173512
    Device Name
    MFI-Cardiac
    Date Cleared
    2018-02-05

    (84 days)

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

    MultiFunctional Imaging, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MFI-Cardiac application is intended to provide processing of rest and stress myocardial perfusion positron emission tomography (PET) images with approved radiotracers that have been acquired with a singlescan or fast back-to-back scans without waiting for radiotracer decay between scans. The application models measurements of tracer uptake over time to aid in the processing of the images. Co-registration or fusion of volumetric data is provided as a quality control. The processed output images are reviewed on other devices by qualified medical professionals trained in the use of medical imaging devices.
    Device Description
    MFI-Cardiac is a software medical device that facilitates the rapid acquisition and processing of rest and stress myocardial perfusion images (MPI) with positron emission tomography (PET) and approved radiotracers. The device processes rest+stress cardiac PET images that have been rapidly acquired using either a single scan with two administrations of the tracer (one at rest, the other at stress) or separate "back-to-back" rest and stress scans. The rapidly acquired rest and stress cardiac PET images are provided to MFI—Cardiac via digital image transfer in DICOM format. In use, the device first performs a series of quality assurance tests to ensure data integrity and validity. The images are then processed to correct for residual activity from the 1st tracer administration (administered at rest) that affects the image obtained after the 2nd tracer injection (administered at stress). The device then outputs separated and corrected DICOM images at rest and stress; these images are offloaded to other devices for display and review by qualified healthcare professionals.
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