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510(k) Data Aggregation

    K Number
    K960602
    Device Name
    SSA-340A (MODIFICATION)
    Manufacturer
    TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
    Date Cleared
    1996-03-21

    (65 days)

    Product Code
    IYN
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K941352
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K941352

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Color Angio is a post-processing modification to the Power Mode display that was cleared with the SSA-340A system in K941352. It is an amplitude based color display subset of color doppler imaging that performs frame addition to accentuate minute vascular structures and signal the presence of blood, rather than the motion of flow. This feature is independent of velocity, angle of incidence and direction of interrogation and reduces the effects of aliasing. It does not change the acoustic output or doppler sensitivity characteristics of the SSA-340A system.

    AI/ML Overview

    This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the device's classification, compliance with performance standards, and a summary of its substantial equivalence to a previously cleared device.

    Therefore, I cannot provide the requested table and information based on the provided text.

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