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510(k) Data Aggregation

    K Number
    K992229
    Device Name
    MXU-125 OR TMX-125
    Manufacturer
    TREX MEDICAL CORP.
    Date Cleared
    1999-08-06

    (35 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K894643,K902610
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K894643, K902610

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

    The MXU-125 or TMX-125 is a Mobile x-ray Unit intended for use in general radiographic medical procedures by a licensed professional.

    Device Description

    The Mobile X-ray Unit is a portable, battery-powered, self-propelled - unit - designed - for - making - film radiographs in a hospital environment. The unit is capable of generating diagnostic x-rays according to the technique factor combinations selected and controlled by the operator.

    AI/ML Overview

    The provided text describes a 510(k) summary for a Mobile X-ray Unit (MXU-125 or TMX-125) and discusses its substantial equivalence to predicate devices. However, it does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.

    The document focuses on:

    • General Information: Manufacturer, contact, device name.
    • Performance Standard: Compliance with 21 CFR Subchapter J (Diagnostic X-ray Equipment Standard).
    • Substantial Equivalence: Listing predicate devices (LORAD RT-125, GE Medical Systems AMX-3) with their 510(k) numbers.
    • Indications for Use: "intended for use in general radiographic medical procedures by a licensed professional."
    • Technological Characteristics: Describing it as a portable, battery-powered, self-propelled unit for film radiographs in a hospital environment, capable of generating diagnostic x-rays. It also mentions compliance with Part 1020, Performance Standards for Ionizing Radiation Emitting Products, and voluntary standards for electrical safety, electromagnetic compatibility, and radiation safety.
    • FDA Clearance Letter: Confirming the review of the 510(k) notification and a finding of substantial equivalence based on the stated indications for use.

    Therefore, I cannot populate the requested table or answer questions 2 through 9, as the necessary information is not present in the provided text.

    The document only states that the device "conforms to 21 CFR Subchapter J (21 CFR 1020.30, 1020.31 and 1020.32 Diagnostic Xray Equipment Standard)" and "complies with Part 1020, Performance Standards for Ionizing Radiation Emitting Products and conforms to recognized voluntary standards for electrical safety, electromagnetic compatibility of medical equipment and radiation safety." These are regulatory compliance statements, not specific acceptance criteria with performance metrics from a study.

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