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510(k) Data Aggregation

    K Number
    K982427
    Device Name
    TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C
    Manufacturer
    TREX MEDICAL CORP.
    Date Cleared
    1998-09-23

    (72 days)

    Product Code
    OWB
    Regulation Number
    892.1650
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    TREX Tilt-C, Integrated C-Arm/Table multipurpose radiographic/fluoroscopic positioning system. It is an all-digital multi-purpose system designed to address a broad variety of radiographic/fluoroscopic, interventional and limited angiographic procedures.

    Device Description

    Integrated C-Arm/Table multipurpose radiographic/fluoroscopic positioning system, Model TREX Tilt-C. It is an all-digital multi-purpose system designed to address a broad variety of radiographic/fluoroscopic, interventional and limited angiographic procedures.

    AI/ML Overview

    This 510(k) premarket notification is for a conventional medical device (TREX Tilt-C, Integrated C-Arm/Table multipurpose radiographic/fluoroscopic positioning system), not an AI/ML powered device. As such, the concept of "acceptance criteria" and "device performance" in the context of an AI model's metrics (like accuracy, sensitivity, specificity) is not directly applicable here.

    The letter primarily focuses on the substantial equivalence determination for regulatory clearance based on the device's adherence to general controls and existing regulations. It does not contain information about studies proving performance against specific acceptance criteria in the manner requested for AI/ML devices.

    Therefore, I cannot provide the requested information.

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