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510(k) Data Aggregation

    K Number
    K092842
    Device Name
    ECHOPLAQUE
    Manufacturer
    INDEC SYSTEMS, INC.
    Date Cleared
    2010-03-01

    (167 days)

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

    INDEC SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    echoPlaque is a software product intended to be used to review, analyze, and measure intravascular ultrasound (IVUS) images. echoPlaque is intended to help qualified medical professionals examine intravascular ultrasound (IVUS) images and make measurements to quantify vessel and stent dimensions. These features aid in post-procedure analysis regarding the placement of interventional devices. echoPlaque is a software product intended to be used to visualize, analyze, and save DICOM and IMG/BMG (INDEC proprietary format) Intravascular Ultrasound (IVUS) images. echoPlaque is intended to allow qualified medical professionals to view, measure, and save new IVUS images. Images can be loaded into the echoPlaque software via removable media (CD/DVD) or hard disk or new images can be acquired from an analog or digital video signal. echoPlaque supports linear, area, and volumetric measurements. Measurements can be exported and images can be saved using echoPlaque. Images can be saved in either a compressed or uncompressed format. These features aid in post-procedure analysis regarding the placement of interventional devices.
    Device Description
    echoPlaque is a software product that provides capabilities for loading, acquiring, viewing, analyzing and saving vendor-neutral, multi-frame DICOM data from Intravascular Ultrasound (IVUS) studies, INDEC echoPlaque IMG/BMG IVUS files, and medical datasets saved as Microsoft Video 1 codec compressed AVI files. echoPlaque's main functionality includes viewing and playback of medical images and ancillary files, acquiring new images from analog and digital signals, image analysis including 2D and volumetric measurements, and the ability to resave multi-frame images in either a compressed or uncompressed format for future visualization and analysis.
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    K Number
    K062985
    Device Name
    IVUS ENHANCER
    Manufacturer
    INDEC SYSTEMS, INC.
    Date Cleared
    2006-11-22

    (54 days)

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

    INDEC SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IVUS Enhancer is a software product intended to be used to review and analyze DICOM images, primarily intravascular ultrasound (IVUS) images. IVUS Enhancer is intended to help qualified medical professionals review DICOM images by adjusting image properties, making simple measurements, and adding annotations for easy export to other applications. These features aid in postprocedure analysis after the placement of interventional devices.
    Device Description
    IVUS Enhancer is a software product that provides capabilities for viewing and interacting with DICOM data from Intravascular Ultrasound (IVUS) studies from all vendors, other DICOM medical image data, and INDEC echoPlaque IMG/BMG IVUS files. IVUS Enhancer's main functionality includes viewing and playback of medical images and ancillary files, minor image analysis including some measurements, and the ability to resave image cross-sections and animations to be used in future presentations.
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    K Number
    K024103
    Device Name
    IVUS PLUS
    Manufacturer
    INDEC SYSTEMS, INC.
    Date Cleared
    2003-01-24

    (43 days)

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

    INDEC SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IVUS Plus is a digital image processing accessory to Boston Scientific's intravascular ultrasound imaging systems, ClearView (K891386) and Insight (K921750). It adds fulllength longitudinal digital display capability, full image rotation capability, and mensuration functions. It is indicated for use in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy
    Device Description
    IVUS Plus will function as an accessory to ClearView and Insight (K891386 and K921750), Boston Scientific's intravascular ultrasound imaging systems. IVUS Plus adds digital image review capability and full-length longitudinal display with full image rotation and mensuration functions.
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