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510(k) Data Aggregation

    K Number
    K110447
    Device Name
    ECHOINSIGHT
    Date Cleared
    2011-05-27

    (100 days)

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

    ULTRASOUND MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended for use by or on the order of a qualified physician for analysis of ultrasound imaging of the human heart. Cardiac (adult and pediatric) applications using B-mode (including harmonic) imaging are supported. The system provides image data analysis applications that supply information on cardiac structure and motion.
    Device Description
    The Echolnsight™ software system enables the production and visualization of 2D tissue motion measurements (including tissue velocities, strain rates) and cardiac structural measurement information derived from tracking speckle in tissue regions visualized in any Bmode (including harmonic) imagery loops as captured by most commercial ultrasound systems. The Echolnsight™ software system has been designed to ingest and process ultrasound imagery stored in files with content organized and encoded in conformance to the following the following standards: - NEMA PS3 (3.3, 3.5, 3.6, 3.10): Digital Imaging and Communications in Medicine . (DICOM), 2008. - ISO/IEC 10918-1:1994-02: Information technology Digital compression and coding of . continuous-tone still images – Requirements and guidelines (JPEG standard), 1994. - ISO/IEC 15444-1:2004: Information technology JPEG 2000 image coding system: . Core coding system, 2004.
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    K Number
    K100363
    Device Name
    ULTRA DCI MODEL 5000
    Date Cleared
    2010-05-21

    (98 days)

    Product Code
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTRASOUND MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ultra DCI 5000 System is intended for use by, or on the order of, a qualified physician for ultrasound imaging of the human heart. The cardiac (adult and pediatric) application using Bmode imaging is supported.
    Device Description
    The Ultra DC1 Model 5000 is a general purpose, mobile, software-controlled, diagnostic ultrasound system designed to provide the user with the ability to collect standard 2D brightness mode (B-mode) echocardiographic views of the heart, visualize these views and store the collected data for later visualization. The device includes a 4-lead electrocardiograpic (ECG) module and patient connections to collect and display a single ECG trace (PQRST wave) along with the B-mode imagery.
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