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510(k) Data Aggregation

    K Number
    K213520
    Device Name
    AXIR-CX
    Manufacturer
    Date Cleared
    2022-08-19

    (289 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Radisen Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AXIR-CX is a software package used with general purpose computing hardware to receive, store, distribute and display chest X-ray images and associated data for patient diagnosis. AXIR-CX is a software application that enable the DICOM-compliant chest X-ray image [14 x 17 or 17 x 17 inch size] from DR and CR, and after image displaying the user adds the annotation regarding the diagnosis and print out the patient information or send to another PACS system. AXIR-CX is intended to be used by trained medical professionals including physicians, radiologists, and medical technicians. This device is not indicated for use in mammography.
    Device Description
    The AXIR software is designed for use by radiologists and radiology technicians for annotation in the Chest X-ray images. The AXIR software is developed to use Radisen Flat Panel DR Detector and Radisen Image Viewer. The purpose of AXIR software is for the doctor to annotate Chest X-ray images and then to print out with patient information or sent to another PACS system. A client user needs to install AXIR-CX first in the recommended PC environment. After installation, the client user chooses a DICOM format in the uploaded patient list to be annotated, and then annotation is written by user after reviewing of image chosen. After annotation has completed it can be printed out, saved or sent to another PACS system.
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    K Number
    K221144
    Device Name
    PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG
    Manufacturer
    Date Cleared
    2022-05-13

    (23 days)

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

    Radisen Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PEDRA Digital Flat Panel X-ray detector is indicated as a digital imaging solution designed for the general radiographic system for human anatomy. It is intended to replace film or screen-based radiographic systems in all general-purpose diagnostic procedures. It is not to be used for mammography.
    Device Description
    The PEDRA are wired or wireless digital flat panel detectors that have been designed for a faster, more streamlined approach to digital stationary X-rav systems. The PEDRA detector utilizes a combination of propriety TFT glass and scintillators (CsI / Gadox), and those and electronics are housed in one package. The detectors support an auto-trigger signal sensing technology that allows the detectors to be used without generator integration. The flat panel sensors of the PEDRA are fabricated using thin-film technology based on amorphous silicon technology. Electronically, the sensors are much like conventional photodiode arrays. Each pixel in the array consists of a light-sensing photodiode and a switching Thin Film Transistor (TFT) in the same electronic circuit. Amorphous silicon photodiodes are sensitive to visible light, with a response curve roughly comparable to human vision. The sensitivity of amorphous silicon photodiodes peaks in green wavelengths, well-matched to scintillators such as CSI and Gadox. The response has the excellent linearity of a charge-integrating-biased photodiode. SDK-Pedracalib(DMS) is the software of Detector that performs image acquisition, image correction, and pre-processing. An x-ray generator (an integral part of a complete diagnostic x-ray system) is not part of this submission.
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