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510(k) Data Aggregation

    K Number
    K252911

    Validate with FDA (Live)

    Date Cleared
    2025-10-09

    (27 days)

    Product Code
    Regulation Number
    892.1680
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Lux HD 2530 Detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all general–purpose diagnostic procedures. Lux HD 2530 Detector is not intended for mammography or dental applications.

    Device Description

    Lux HD 2530 Detector is digital flat panel detector. They support the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 25cm × 30cm (Lux HD 2530 Detector). The differences between two models are overall change in the dimensions of the image receptor.

    The sensor plate of Lux HD 2530 Detector is direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface.

    The major function of the Lux HD 2530 Detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging.

    The Digital Radiographic Imaging Acquisition Software Platform - DR is part of the system, it is used to acquire, enhance, view image from Lux HD 2530 Detector. Based on the risks and intended use, documentation level of the software is basic.

    AI/ML Overview

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