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510(k) Data Aggregation

    K Number
    K051334
    Device Name
    TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER
    Manufacturer
    TERATECH CORP.
    Date Cleared
    2005-06-03

    (11 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K992505,K012191,K010883,K010003,K030199,K040840,K043278,K991710
    Why did this record match?
    Device Name :

    TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER

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

    The TERASON™ Ultrasound System with Continuous Wave (CW) Doppler is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.

    Device Description

    The TERASON™ Ultrasound System with Continuous Wave (CW) Doppler introduces two new versions of the TERATECH Model 2000 Imaging System.

    AI/ML Overview

    The provided document is a 510(k) summary for the TERASON™ Ultrasound System with Continuous Wave (CW) Doppler. It outlines the device's intended use and substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

    Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on specific performance studies with acceptance criteria, sample sizes, ground truth establishment, or expert evaluations.

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