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510(k) Data Aggregation

    K Number
    K223010
    Device Name
    Portable X-ray System
    Manufacturer
    iRay Technology Taicang Ltd.
    Date Cleared
    2023-01-17

    (110 days)

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

    iRay Technology Taicang Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portable X-ray System is used as a portable, extra oral x-ray source for producing diagnostic x-ray images using conventional film, PSP (phosphor plates) or digital sensors. It is intended for adult and pediatric patients. This equipment is available only to trained and qualified dentist or dental technician.
    Device Description
    The portable X-Ray system, Canis014D07, is intended to be used by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic x-ray images using intraoral image receptors. The images presented in the product screen are for preview purposes only, not for imaging diagnosis. It also includes accessories, which are battery, recharging unit and hand switch.
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    K Number
    K222886
    Device Name
    Mercu 1717V
    Manufacturer
    iRay Technology Taicang Ltd.
    Date Cleared
    2022-10-20

    (27 days)

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

    iRay Technology Taicang Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mercu1717V Digital Flat Panel 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. The device is not intended for mammography or dental applications.
    Device Description
    Mercu1717V Digital Flat Panel Detectors (Hereinafter referred to as Mercu1717V) supports dynamic imaging and static imaging. The sensor plate of Mercu1717V 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 cable. The major function of the Mercu1717V is to convert the X-ray to digital image, with the application of high-resolution X-ray imaging. Mercu1717V can get single image and it also can get dynamic image. Both kinds of detectors are the key component of DR system, enable to complete the digitalization of the medical X-ray imaging with the DR system software. The iRay DR used for digital X-ray radiography image from the digital flat panel detectors. iRay DR is used to handle the DICOM protocol (DICOM 3.0). iRay DR has many functions such as image acquisition, image enhancement processing and editing image or information.
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    K Number
    K221714
    Device Name
    Flat Panel Detector
    Manufacturer
    iRay Technology Taicang Ltd.
    Date Cleared
    2022-06-29

    (16 days)

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

    iRay Technology Taicang Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Venul 717X 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 general-purpose diagnostic procedures.
    Device Description
    Venu1717X is a cassette-size tethered X-ray flat panel detector based on amorphous silicon thin-film transistor technology. It is designed to provide the high quality radiographic image which contains an active matrix of 3070×3070 with 139um pixel pitch. The scintillator of Venu1717X is CsI(Caesium Iodide). The technology of CsI direct growth reduces the exposure dose and improves the image quality. Since Venu1717X supports multiple trigger modes, it can satisfy both of the general DR system and retrofit DR system. iRay SDK(include iDetector) is intend to supply API interface for DR system manufacturers.DR system manufacturer control the detector by SDK interface. SDK is not intended to be used directly by other users beside DR system manufacturers. The iRay SDK is unchanged from the predicate device.
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    K Number
    K221345
    Device Name
    Wireless Digital Flat Panel Detector
    Manufacturer
    iRay Technology Taicang Ltd.
    Date Cleared
    2022-06-16

    (38 days)

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

    iRay Technology Taicang Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Luna 1012X wireless digital flat panel 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. The device is not intended for mammography or dental applications.
    Device Description
    Luna1012X Wireless Digital Flat Panel Detector (Hereinafter referred to as Luna1012X) is the kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 31.52cm×25.02cm. The sensor plate of Luna1012X 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 Luna1012X 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, enable to complete the digitalization of the medical X-ray imaging with the DR system software. iRay SDK(include iDetector) is intended to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to be used directly by other users beside DR system manufacturers.
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    K Number
    K220536
    Device Name
    Digital flat panel detector
    Manufacturer
    iRay Technology Taicang Ltd.
    Date Cleared
    2022-04-28

    (63 days)

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

    iRay Technology Taicang Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Venul 748V flat panel detector is provided as an imaging component to the system manufacturer. It is mainly used in long bones, spine and other inspection fields. After collecting static imaged data is output to the processing equipment. This device is suitable for providing radiography imaging for adult via DR system. The remaining notes depend on the final DR system. It is not intended for mammography, dental applications, neonatal and fluoroscopy.
    Device Description
    Digital flat panel detector is a cassette-size wired X-ray flat panel detector based on amorphous silicon thin-film transistor technologies. It was developed to provide X -Ray image, which contains an active matrix of 3064×8696 with 139um pixel pitch. Detector's scintillator is CsI(Cesium iodide). The biggest feature of Venu1748V is that it supports imaging of large-scale objects, including long bones and complete spine detection.
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    K Number
    K220668
    Device Name
    Wireless Digital Flat Panel Detector
    Manufacturer
    iRay Technology Taicang Ltd.
    Date Cleared
    2022-04-01

    (25 days)

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

    iRay Technology Taicang Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wireless digital flat panel 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. The device is not intended for mammography or dental applications.
    Device Description
    Mars1013X Wireless Digital Flat Panel Detector (Hereinafter referred to as Mars1013X) is the kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 33.18cm×25.28cm. The sensor plate of Mars1013X is direct-deposited with CsI(Cesium Iodide) 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 Mars1013X 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, enable to complete the digitalization of the medical X-ray imaging with the DR system software. iRay SDK(include iDetector) is intended to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to be used directly by other users beside DR system manufacturers.
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    K Number
    K213529
    Device Name
    Focus HD 43 Detector
    Manufacturer
    iRay Technology Taicang Ltd.
    Date Cleared
    2022-03-29

    (145 days)

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

    iRay Technology Taicang Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Focus HD 43 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 generalpurpose diagnostic procedures. The device is not intended for mammography or dental applications.
    Device Description
    Focus HD 43 Detector is a kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 42.67cm×42.67cm. The sensor plate of Focus 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 Focus 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, enable to complete the digitalization of the medical X-ray imaging with the DR system software. SDK(include iDetector) is intended to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to be used directly by other users beside DR system manufacturers.
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    K Number
    K213646
    Device Name
    Focus HD 35 Detector
    Manufacturer
    iRay Technology Taicang Ltd.
    Date Cleared
    2022-03-29

    (145 days)

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

    iRay Technology Taicang Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Focus HD 35 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 generalpurpose diagnostic procedures. The device is not intended for mammography or dental applications.
    Device Description
    Focus HD 35 Detector is a kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 35cm×43cm. The sensor plate of Focus HD 35 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 Focus HD 35 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, enable to complete the digitalization of the medical X-ray imaging with the DR system software. SDK(include iDetector) is intended to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to be used directly by other users beside DR system manufacturers.
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    K Number
    K220422
    Device Name
    Dental sensors NanoPix1, NanoPix2
    Manufacturer
    iRay Technology Taicang Ltd.
    Date Cleared
    2022-03-11

    (25 days)

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

    iRay Technology Taicang Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Sensors, models NanoPix1 and NanoPix2 are intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists. This device must only be used in hospital environments, clinics or dental offices by trained and qualified dental personnel, and not used in the oxygenrich environment. This device is suitable for providing dental radiography imaging for both adult and pediatric.
    Device Description
    Dental Sensors, models NanoPix1 and NanoPix2, are feature 20um pixel pitch CMOS sensor with directly deposited CsI:Tl scintillator which ensures optimal resolution. An easy to use hi-speed direct USB interface enables a simple connection to a PC without need for an additional control box. The intra-oral software application makes it easy to acquire, enhance, analyze, view and share images from the sensor. The major function of NanoPix1 and NanoPix2 are to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This detector is the key component of NanoPix system, enables to complete the digitalization of the medical X-ray imaging with the NanoPix software.
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    K Number
    K212279
    Device Name
    Digital Intraoral X-ray Imaging System
    Manufacturer
    iRay Technology Taicang Ltd.
    Date Cleared
    2021-10-07

    (79 days)

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

    iRay Technology Taicang Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Digital intraoral X-ray Imaging System, models i-Sensor H2, are used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination, the diagnosis of structural diseases of teeth, jaws and mouth. 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 Digital intraoral X-ray Imaging System, models i-Sensor H1 and i-Sensor H2, are the digital intra-oral sensor. It features a 20um pixel pitch CMOS sensor with directly deposited CsI:Tl scintillator which ensures optimal resolution. An easy to use hispeed direct USB interface enables a simple connection to a PC without need for an additional control box. The optional intra-oral software application makes it easy to acquire, enhance, analyze, view and share images from the sensor. The major function of i-Sensor H1 and i-Sensor H2 are to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This detector 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.
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