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510(k) Data Aggregation

    K Number
    K974504
    Device Name
    EPS
    Manufacturer
    E FOR M IMAGING SYSTEMS DIV., MARQUETTE ELECTRONIC
    Date Cleared
    1998-02-27

    (88 days)

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

    E FOR M IMAGING SYSTEMS DIV., MARQUETTE ELECTRONIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EPS system is a digital recording system designed for use as an electronic photospot device on OEM manufactured Radiographic & Fluoroscopic ("R/F") systems. The system is modular in configuration allowing single and dual room configurations for acquisition and/or review, providing assistance to Radiologic Technologists in routine diagnostic examinations and special procedures in R/F. The EPS system may be used to acquire, display, record, archive, and disseminate digital R/F image data.
    Device Description
    The Electronic PhotoSpot (EPS) is a 10 bit PC based multitasking acquisition/display system configured for use in R/F applications. This system is designed for use by a qualified Radiologic Technologist. More specifically, the EPS system is a digital recording system designed for use as an electronic photospot device on OEM manufactured R/F systems. This system consists of independent and simultaneous acquisition of data, review, post processing of raw data and archive transfer functions. The system is modular in configuration allowing single and dual room configurations for acquisition and/or review. The system has 10 bit, 1024 digital acquisition, display and storage capability and uses a Windows based operator interface on the Operator Console/Review Station. It includes the following major components (minimally): Pentium computers, Image monitor(s), Camera X-Ray Interface, MOD media for archival, Software program developed by Marquette Medical Systems to run in conjunction with Microsoft Windows NT. The EPS provides image acquisition, display, archival, and exchange media compliant with the DICOM 3.0 standard. Furthermore, the EPS allows connection to the medical facility's existing LAN network for data dissemination to support reviews, reports, and patient billing.
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    K Number
    K955184
    Device Name
    ACCULUPE
    Manufacturer
    E FOR M IMAGING SYSTEMS DIV., MARQUETTE ELECTRONIC
    Date Cleared
    1996-01-24

    (72 days)

    Product Code
    LMB
    Regulation Number
    892.2010
    Why did this record match?
    Applicant Name (Manufacturer) :

    E FOR M IMAGING SYSTEMS DIV., MARQUETTE ELECTRONIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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