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510(k) Data Aggregation

    K Number
    K243556
    Device Name
    Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)
    Manufacturer
    iRay Imaging Technology (Haining) Limited
    Date Cleared
    2025-03-18

    (120 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    iRay Imaging Technology (Haining) Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lux HD 35 Detector and Lux HD 43 Detector are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. Lux HD 35 Detector and Lux HD 43 Detector are not intended for mammography or dental applications.
    Device Description
    Lux HD 35 Detector and Lux HD 43 Detector are digital flat panel detector. They support the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 35cm×43cm (Lux HD 35 Detector)/42.67cm × 42.67cm (Lux HD 43 Detector) .The differences between two models are overall change in the dimensions of the image receptor. The sensor plate of Lux HD 35 Detector and Lux HD 43 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 35 Detector and Lux HD 43 Detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Both kinds of detectors are the key component of DR system. The Digital Radiographic Imaging Acquisition Software Platform - DR is part of the system, it is used to acquire, enhance, view image from Lux HD 35 Detector and Lux HD 43 Detector.
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    K Number
    K230998
    Device Name
    Digital Wireless Intraoral X-Ray Sensor
    Manufacturer
    iRay Imaging Technology (Haining) Limited
    Date Cleared
    2023-10-20

    (196 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    iRay Imaging Technology (Haining) Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Digital Wireless Intraoral X-Ray Sensor (Pluto0002XW) is used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination and the diagnosis of structural diseases. The product is expected to be used in hospitals and clinics, operated and used by trained professionals under the guidance of doctors. This device is not intended for mammography and conventional photography applications. This device is suitable for providing dental radiography imaging for both adult and pediatric.
    Device Description
    The Pluto0002XW Digital Wireless Intraoral X-Ray Sensor (Hereinafter referred to as Pluto0002XW) contains the digital intra-oral sensor. It features a 20um pixel pitch CMOS sensor with directly deposited CsI:Tl scintillator which ensures optimal resolution. The major function of the Pluto0002XW is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Pluto0002XW is the key component of intra-oral DR system, enables to complete the digitalization of the medical X-ray imaging with the intra-oral DR system software. The iRay intra-oral software (iRayDR) is part of the system, it is used to acquire, enhance, analyze, view and share images from the sensor.
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    K Number
    K230811
    Device Name
    Digital Intraoral X-Ray Sensor
    Manufacturer
    iRay Imaging Technology (Haining) Limited
    Date Cleared
    2023-04-21

    (28 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    iRay Imaging Technology (Haining) Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used in conjunction with a pulsed dental X-ray machine, the CS 6200 is intended for medical institutions to perform static digital X-ray imaging facilitating the diagnosis of the teeth, jaw, mouth, and other structural diseases.
    Device Description
    The CS 6200 is a USB-driven digital intraoral X-ray sensor based on CMOS technology that is specially designed for acquiring real-time high-quality dental diagnostic images. Image data acquired from the device can be transmitted via a USB 2.0 port to a workstation for display and processing.
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