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510(k) Data Aggregation

    K Number
    K241505
    Device Name
    DRX-Revolution Mobile X-ray System
    Manufacturer
    Carestream Health Inc.
    Date Cleared
    2024-12-10

    (196 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K163203,K223842,K150766,K153142,K183245,K203159,K202441,K191025
    Why did this record match?
    Reference Devices :

    K163203, K223842, K150766, K153142, K183245, K203159, K202441

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

    The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.

    Device Description

    The DRX-Revolution Mobile X-ray System is a mobile diagnostic x-ray system that utilizes digital technology for bedside or portable exams. Key components of the system are the x-ray generator, a tube head assembly (includes the x-ray tube and collimator) that allows for multiple axes of movement, a maneuverable drive system, touchscreen user interface(s) for user input. The system is designed with installable software for acquiring and processing medical diagnostic images outside of a standard stationary X-ray room. It is a mobile diagnostic system intended to generate and control X-rays for examination of various anatomical regions.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the DRX-Revolution Mobile X-ray System, which includes changes such as the addition of Smart Noise Cancellation (SNC) functionality and compatibility with a new detector (Lux 35). The study focuses on demonstrating the substantial equivalence of the modified device to a previously cleared predicate device (DRX-Revolution Mobile X-ray System, K191025).

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided information:

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria (for SNC)Reported Device Performance
    At least 99% of all image pixels were within ± 1 pixel valueAchieved. The results demonstrated that at least 99% of all image pixels were within ± 1 pixel value.
    Absolute maximum difference across all test images should be ≤ 10-pixel valuesAchieved. The absolute maximum difference seen across all test images was 3-pixel values, meeting the acceptance criterion of a maximum allowable difference of 10-pixel values.
    Noise ratio values computed for every pixel of the test images should be
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