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510(k) Data Aggregation

    K Number
    K023112
    Device Name
    PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9
    Manufacturer
    PROBLEM SOLVING CONCEPTS, INC.
    Date Cleared
    2002-12-17

    (89 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROBLEM SOLVING CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ProSolv® CardioVascular is intended for use by doctors and non-physicians (e.g., sonographers, technicians, nurses) who are affiliated with medical labs that use images obtained from digital-imaging DICOM instruments (echo, vascular, nuclear cardiology, cardiac catheterization, MRI, etc.) The ProSolv® CardioVascular image management and reporting system is software that operates on standard PC equipment using Windows 95 or later operating system. ProSolv® CardioVascular provides the functionality for archiving, viewing, measuring, analyzing, and reporting digital studies generated by digital-imaging instruments from a multitude of manufacturers. The software is available in several configurations: Administrator (report viewing, edit patient demographic information), Viewer (image and report viewing, basic measurements), and Analyzer (Viewer features plus measurements, qualitative assessment, and report creation and design). The software can be used in a variety of network configurations ranging from a stand-alone workstation to a network of workstations connected through TCP/IP networking to a ProSolv® DICOM Server. The DICOM Server permits studies to be transferred from DICOM compatible imaging instruments directly to a ProSolv® database using TCP/IP.
    Device Description
    The ProSolv® CardioVascular software operates on a PC computer using the Windows 95 or later operating system. ProSolv® CardioVascular Viewer allows the user to view medical images acquired from digital-imaging instruments, track examinations and patient data with a database, and view reports. The software can display DICOM images and most non-DICOM images. ProSolv® CardioVascular Analyzer includes all the functionality of the Viewer plus routine and stress echo regional wall motion analysis, qualitative and quantitative image evaluation, report generation, and customizable reports, measurements, and comment lists. Each of the products can be packaged with the optional ProSolv® CardioVascular Server capability to allow remote database access over a network.
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    K Number
    K993750
    Device Name
    PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROSOLV ECHOSERV, PROSOLV ECHO
    Manufacturer
    PROBLEM SOLVING CONCEPTS, INC.
    Date Cleared
    2000-02-02

    (89 days)

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

    PROBLEM SOLVING CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ProSolv® Echo is stand-alone software that operates on standard PC equipment. The device is available in three configurations (EchoViewer, EchoViewer SE, and EchoAnalyzer) and is intended for use by echocardiographic labs. ProSolv® EchoViewer is also intended for use by cardiac catheterization labs. ProSolv® Echo incorporates the latest technology in archiving, viewing, measuring, and reporting digital echocardiographic studies generated by a multitude of ultrasound manufacturers. The device configurations can be packaged with ProSolv® EchoServer to extend the capabilities for laboratories wanting to access a remote, secure database and archive images over the Internet.
    Device Description
    The ProSolv® Echo software operates on a PC computer using the Windows 95/98/NT operating system. ProSolv® EchoViewer allows the user to view echocardiographic and cardiac catheterization images from a variety of sources, track examinations and patient data with a database, and view reports. DICOM images and most non-DICOM images can be read by the software. ProSolv® EchoViewer SE adds to the EchoViewer by including Stress Echo regional wall motion analysis, qualitative image evaluation with a customizable comment list, and report generation. ProSolv® EchoAnalyzer includes all the functionality of EchoViewer SE, plus quantitative image evaluation, routine regional wall motion scoring, and customizable reports and measurements. Each of the products can be packaged with the optional ProSolv® EchoServer capability to allow remote database access via the Internet.
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