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510(k) Data Aggregation

    K Number
    K200469
    Device Name
    PAPAYA 3D Premium & PAPAYA 3D Premium Plus
    Manufacturer
    Genoray Co.,Ltd
    Date Cleared
    2020-09-16

    (203 days)

    Product Code
    OAS, MUH
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Genoray Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The X-ray unit system is a diagnostic imaging system which consists of multiple image acquisition modes; panoramic, cephalometric, and CBCT (Cone Beam Computed Tomography). X-ray unit system is used for dental radiographic examination and diagnosis of teeth, jaw, oral structures and skull. The device is to be operated and used by dentists and other legally qualified professionals.
    Device Description
    The proposed device PAPAYA 3D Premium Plus the computed tomography x-ray system which consists of image acquisition modes; panorana, cephalometric, and computed tomography. The difference between PAPAYA 3D Premium Plus is only optional of the cephalometric detector. It designed for dental radiography of the oral and cranionarial as teeth, jaws and oral structures. The device with cephalometric detector is named PAPAYA 3D Premium Plus and the device without cephalometric detector is named PAPAYA 3D Premium. The proposed device are composed of flat panel x-ray detectors which are based on CMOS, and TFT detector types and divided in to CT, panoramic and cephalometric radiography, and x-ay tube. CMOS, and TFT detectors are used to capture scamed image for obtaining diagnostic information for craniofacial surgery or other treatments. And it also provides 3D the anatomic stuctures by acquiring 3609rotational image sequences of oral and craniofacial area.
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    K Number
    K182614
    Device Name
    RCT700
    Manufacturer
    RAY Co.,Ltd
    Date Cleared
    2018-10-16

    (25 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAY Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CBCT, panoramic x-ray imaging system with cephalostat, is an extra oral source x-ray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBVT technique, to generate dental maxillofacial 3D images. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. 2D Image is obtained using the standard narrow beam technique.
    Device Description
    RCT700 is 3D computed tomography for scanning hard tissues like bone and teeth. By rotating the c-arm which is embedded with high voltage generator all-in-one x-ray tube and a detector on each end, CBCT images of dental maxillofacial is attained by recombining data from the same level that are scanned from different angle. Panoramic image scanning function for attaining image of whole teeth, cephalometric scanning option for attaining cephalic image, and Model Scan option for attaining dental model CBCT image are included.
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    K Number
    K172180
    Device Name
    OSCAR 15
    Manufacturer
    Genoray Co.,Ltd
    Date Cleared
    2018-02-09

    (205 days)

    Product Code
    OWB, JAA
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Genoray Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OSCAR 15 is a mobile fluoroscopy system is designed to provide fluoroscopic and spot film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac and critical care. The system may be used for other imaging applications at the physician's discretion.
    Device Description
    OSCAR 15 is consist of X-ray Tube, X-ray tube assembly, x-ray controller, detector and accessories. There is no wireless function in this device. The OSCAR 15, C-Arm Mobile is the device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This device is used for providing fluoroscopic and radiographic images of patient anatomy, especially during the special procedures in a hospital or medical clinics. The fluoroscopic mode of operation is very useful to the attending physician to see the images on real time without the need to develop individual films.
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    K Number
    K160525
    Device Name
    RCT700
    Manufacturer
    RAY CO.,LTD
    Date Cleared
    2016-06-20

    (116 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAY CO.,LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CBCT, panoramic x-ray imaging system with cephalostat, is an extra oral source x-ray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBVT technique, to generate dental maxillofacial 3D images. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. 2D Image is obtained using the standard narrow beam technique.
    Device Description
    RCT700 is 3D computed tomography for scanning hard tissues like bone and teeth. By rotating the c-arm which is embedded with high voltage generator all-in-one x-ray tube and a detector on each end, CBCT images of dental maxillofacial is attained by recombining data from the same level that are scanned from different angle. Panoramic image scanning function for attaining image of whole teeth, and cephalometric scanning option for attaining cephalometric image are included.
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    K Number
    K143000
    Device Name
    RIS500
    Manufacturer
    RAY CO.,LTD
    Date Cleared
    2015-01-23

    (98 days)

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

    RAY CO.,LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This system is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, views and manipulated for diagnostic use by dentists.
    Device Description
    RIOSensor(Model RIS500) is intended to acquire real-time, clinical digital intraoral X-ray images using a solid-state imaging sensor. This system consists of the CMOS sensor and software for image display. This system senses the onset of the X-ray exposure and automatically acquires and save the image data to a PC (software).
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