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510(k) Data Aggregation

    K Number
    K031066
    Device Name
    VIEWMATE ULTRASOUND IMAGING SYSTEM
    Manufacturer
    EP MEDSYSTEMS
    Date Cleared
    2003-10-17

    (197 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VIEWMATE ULTRASOUND IMAGING SYSTEM

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

    The ViewMate System is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the EP MedSystems ViewMate® System and ViewFlex™ Ultrasound Catheter. It declares the device substantially equivalent to legally marketed predicate devices.

    The document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. It primarily focuses on the regulatory clearance process, the intended use of the devices, and the associated regulations.

    Therefore, I cannot provide the requested information from the given input.

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