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510(k) Data Aggregation

    K Number
    K103554
    Device Name
    METRON-CP/MD
    Manufacturer
    EPONATECH LLC
    Date Cleared
    2011-12-20

    (382 days)

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

    EPONATECH LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EponaTech Metron-CP/MD is a clinical imaging software application for use with DR and CR radiography systems, primarily focused on chiropractic and podiatry use. Metron-CP/MD standard processes images using state of the art filtering techniques from various imaging sources and then makes them available to display, annotate, calibrate, mark-up, analyze, store, print and distribute using standard PC hardware. Metron-CP/MD stores and organizes the images (radiographs, ultrasounds, photographs, etc), and provides many various tools and algorithms to produce the best image possible from the imaging hardware. The filters are customizable by the user and organized in Metron-CP/MD's searchable database for later review. Metron-CP/MD also supports adding notes, taking accurate physical measurements, and producing other mark-ups to aid in analysis over time. Metron-CP/MD is currently intended for chiropractic, podiatry use, and general human radiography. It is not intended for mammography use. Metron-CP/MD's features advance imaging algorithms, calibration and measurement tools, multi-imaging stitching, report generation, and full compliance with voluntary Digital Imaging and Communications in Medicine (DICOM) Standard. The filters are customizable by the users and organized in Metron-CP/MD's searchable database for later review. Users then have the ability to put together multi-page formatted reports that can be used in connection with other documents. (See 21 CFR 892.2050) In accordance with 21 CFR 801 Subpart D, the software is intended for prescription use.
    Device Description
    Metron-MD is a clinical software program that allows medical professionals to acquire, display, manipulate and archiving medical images. It offers features (e.g. annotation, zoom, calibration, mark-up, measurement, etc.) routinely used by medical professionals, such as radiologists and orthopedists. Metron-MD supports the DICOM standard and accepts file formats including JPEG, Bitmap, TIFF, avi, and DICOM. Metron-MD runs on Windows based PC-compatible computers, accepts existing image files, and captures images and videos from capture devices such as USB video cameras, CR and DR systems, Digital Camera Media, and TWAIN images sources, etc.
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