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510(k) Data Aggregation

    K Number
    K971776
    Device Name
    ECHOVACS
    Manufacturer
    VMI TECHNOLOGIES
    Date Cleared
    1997-07-14

    (62 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K963610
    Predicate For
    K990052
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    EchoVACS™ is indicated for the capture, archiving, retrieval and display of echocardiography images. It permits annotation of images as well as recording and analysis of workload statistics. It also permits report generation from a comprehensive internal lexicon of anatomic and diagnostic terms covering adult, pediatric and fetal echocardiography.

    Device Description

    EchoVACS™ is an all-digital networked system that is intended to give the echocardiography department a solution for the capture, storage, retrieval and reporting of full-length echocardiograms. EchoVACS™ consists of three modules:

    • Capture station this is connected to the ultrasound machine and . acquires the patient's echo exam. The images are compressed using MPEG (Moving Pictures Expert Group) which is an ISO standard (ISO/IEC 11172). Once captured, the exam is available to any station on the network.
    • Review station this is connected to the network and is used to both view . echo exams and to generate the physician's report.
    • Database server this supports the Capture and Review stations by . providing centralized functionality such as the storage of patient demographics.
    AI/ML Overview

    The provided text is a 510(k) Summary for the EchoVACS™ system, a Picture Archiving and Communications System (PACS) for ultrasound images. It describes the device, its intended use, and substantial equivalence to a predicate device.

    However, the document does not contain information about:

    • Acceptance criteria for device performance.
    • A study proving the device meets acceptance criteria.
    • Sample sizes for test or training sets.
    • Data provenance.
    • Number of experts or their qualifications.
    • Adjudication method.
    • Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
    • Standalone performance.
    • Type of ground truth used or how it was established.

    The 510(k) summary focuses on the device's functionality and its substantial equivalence to a legally marketed predicate device (ALI UltraPACS system, K963610) based on user features. It is a regulatory submission describing the device, not a clinical or performance study report.

    Therefore, I cannot provide the requested information based on the given input.

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