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510(k) Data Aggregation

    K Number
    K984414
    Device Name
    XRE COLLIMATOR WITH SPECTRAL FILTER
    Manufacturer
    TREX MEDICAL CORP.
    Date Cleared
    1998-12-30

    (20 days)

    Product Code
    IZW
    Regulation Number
    892.1610
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K990977,K993683,K053303,K132034
    Why did this record match?
    Reference Devices :

    K990977, K993683, K053303, K132034

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

    The XRE Collimator with spectral filter is designed to be the primary X-ray beam limiting device as part of an angiographic imaging system and is controllable manually and automatically. It also provides a means of manual or automatic selection of filtration designed to reduce the xray dose applied to the patient while still providing high quality images. It is designed to be operated by professional medical personnel only.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the "XRE Collimator with Spectral Filter" and an "Indications for Use Statement". It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth, or adjudication methods.

    Therefore, I cannot provide the requested information based on the input text. The provided text only confirms that the device has received FDA clearance for marketing based on substantial equivalence to a predicate device.

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