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510(k) Data Aggregation

    K Number
    K113052
    Device Name
    INFINIX-CCI
    Manufacturer
    TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
    Date Cleared
    2011-11-22

    (40 days)

    Product Code
    MQB,MOB
    Regulation Number
    892.1680
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K081621
    Why did this record match?
    Device Name :

    INFINIX-CCI

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

    This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

    Device Description

    This device in an x-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm , that is equipped with an x-ray tube, beam limiter and x-ray receptor, x-ray controller, computers with system and processing software, and a patient radiographic table.

    AI/ML Overview

    The provided text is a 510(k) summary for the Toshiba America Medical Systems, Inc. INFX-8000C w/Spot Fluoro Option. This document describes a modification to an existing device, an interventional X-ray system, to improve workflow and reduce radiation exposure via auto-collimation.

    However, the 510(k) summary does not contain information about acceptance criteria or a study designed to prove the device meets specific performance metrics.

    Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, details of MRMC or standalone studies, or ground truth information based solely on the provided text.

    The document primarily focuses on establishing substantial equivalence to a predicate device (INFX-8000C K081621) due to a modification for workflow improvement and radiation dose reduction, rather than presenting a performance study with detailed acceptance criteria. The modification is specifically noted as: "The modification allows for the auto-collimation to a smaller field of few that the operator sets on the last image displays (LIH)."

    The safety section mentions compliance with regulations like Quality System Regulations, ISO 13485, IEC60601-1 standards, and 21 CFR §1020, but these are general regulatory compliances, not specific performance acceptance criteria for a new feature validated by a study.

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