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510(k) Data Aggregation

    K Number
    K201503
    Device Name
    Edge Air(1417) Digital Flat Panel X-ray Detector
    Manufacturer
    Osko, Inc.
    Date Cleared
    2020-06-29

    (24 days)

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

    Osko, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Edge Air(1417) Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general purpose diagnostic procedures. Not to be used for mammography.
    Device Description
    Edge 40(1417) is a wired/wireless digital solid state X-ray detector that is based on flat-panel technology. The wireless LAN (IEEE 802.11a/g/w/ac) communication signals images captured to the system and improves the user operability through high-speed processing. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize X-ray images for radiographic diagnosis The RAW files can be further processed as DICOM compatible image files by a separate console SW program (K190866 / Xmaruview V1 (Xmaru Chiroview, Xmaru Podview) / Rayence Co., Ltd.) for a diagnostic analysis.
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    K Number
    K172681
    Device Name
    Edge Air Digital Flat Panel X-ray Detector
    Manufacturer
    OSKO, INC.
    Date Cleared
    2017-10-06

    (30 days)

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

    OSKO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Edge Air Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general purpose diagnostic procedures. Not to be used for mammography.
    Device Description
    Edge Air is a wired/wireless digital solid state X-ray detector that is based on flat-panel technology. The wireless LAN (IEEE 802.11a/g/n/ac) communication signals images captured to the system and improves the user operability through high-speed processing. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize Xray images for radiographic diagnosis The RAW files can be further processed as DICOM compatible image files by a separate console SW program (K160579 / Xmaru View V1 and Xmaru PACS/ Rayence Co., Ltd.) for a diagnostic analysis.
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    K Number
    K172682
    Device Name
    Edge Digital Flat Panel X-ray Detector
    Manufacturer
    Osko, Inc.
    Date Cleared
    2017-10-06

    (30 days)

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

    Osko, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Edge is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general purpose diagnostic procedures. Not to be used for mammography.
    Device Description
    Edge digital flat panel X-ray detector is based on flat-panel technology. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize X-ray images for radiographic diagnosis. The RAW files can be further processed as DICOM compatible image files by separate console SW (K160579 / XmaruView V1 and XmaruPACS/ Rayence Co.,Ltd.) for a radiographic diagnosis and analysis.
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    K Number
    K163048
    Device Name
    Smart Stitching Software System, Image Processing, Radiological
    Manufacturer
    OSKO, INC.
    Date Cleared
    2017-07-28

    (269 days)

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

    OSKO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Smart Stitching software is indicated for use to allow post-capture positioning and joining of individual images to produce an additional composite image for two dimensional image review.
    Device Description
    Smart Stitching provides a function to read multiple medical images at one time by stitching them to one image based on overlapping areas. It supports DICOM 3.0 which is standard of medical image format as well as Tiff and Raw images. It provides additional functions such as image retrieval, storage, and transmission. Smart Stitching is designed to facilitate diagnosis by easily stitching multiple medical images, up to 5 images, from multiple captures to one image. Smart Stitching software does not serve as acquisition software nor has control function for acquisition setting.
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    K Number
    K150663
    Device Name
    Diagnostic X-ray System
    Manufacturer
    OSKO, INC.
    Date Cleared
    2015-05-07

    (52 days)

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

    OSKO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XR5 diagnostic X-ray system is intended for use on adult and pediatric patients for taking diagnostics radiographic exposure of all body parts and operated by a qualified/trained doctor or technician. The XR5 diagnostic X-ray system is designed to be used with conventional film/screen, CR cassettes or digital detectors. NOT intended for Mammography use.
    Device Description
    The XR5 diagnostic X-ray system is used for image capture by using X-rays on a patient's body. The XR5 is a conventional X-ray machine, with an intuitive operation console to provide the user an easy way to manage optimal conditions for quality images. The high frequency generator is capable of delivering the exposition dose appropriate for general X-ray and diagnostic images of a patient. This system is made to use other detector options including: conventional films, CR, or Digital Flat Panel Detectors. Please note that the quality of the image in any detector depends on the manufacture of the receptor device. The XR5 diagnostic X-ray system doesn't provide an AEC feature.
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    K Number
    K150506
    Device Name
    ELIAN Digital Diagnostic X-ray System
    Manufacturer
    OSKO, INC.
    Date Cleared
    2015-04-08

    (41 days)

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

    OSKO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ELIAN diagnostic X-ray system is intended for use on adult and pediatric patients radiographic exposure of all body parts and operated by a qualified/trained doctor or technician. NOT intended for Mammography use.
    Device Description
    The ELIAN is a digital radiographic image acquisition device. It is a fully integrated image capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment. The ELIAN system includes a Detector Panel, Soft Ware, Case, Grid, Power Box, Switch Box, Interconnecting Cables, U-arm Mechanical and Generator. The Detector Panel is an indirect conversion device in the form of a rectangular plate in which the input x-ray photons are absorbed in an a-Si layer with CSI. The Power Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Flugel SW transfers signals between the Detector and X-ray Generator and also indicates the status of the panel using console. Finally, the Flugel SW contains for image data capture and correction of defects on the image data.
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