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510(k) Data Aggregation

    K Number
    K190300
    Device Name
    BIOK7600W Wireless Flat Panel Detector
    Date Cleared
    2019-03-13

    (29 days)

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

    Biokinemetrics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BIOK 7600W is intended for use by a qualified doctor or technologist on both adult and pediativ for taking diagnostic radiographic exposures of all body parts of the patients. The BIOK 7600W provides digital image capture and is intended to replace radiographic film/screen. The x-ray generator, x-ray tube and associated equipment are not provided with the proposed sensor. Prescription use only. The BIOK7600W is not intended for mammography.
    Device Description
    The BIOK7600W sensor is a wireless digital radiography sensor which automatically collects x-ray images from an x-ray source. The BIOK7600W sensor (flat panel type) collects x-rays and digitizes the images for their transfer and display to a computer. The sensor does not have an x-ray source, which is provided by independent manufacturers. The sensor includes a flat panel for x-ray acquisition and a computer (including proprietary processing software) for processing, annotating and storing x-ray images. An X-ray generator with a minimum voltage output range between 55 to 120 kVp and a minimum power of 30 KW can be used with the BIOK7600. The BIOK7600 does not connect to the generator. It automatically detects x-rays and enables the image acquisition (AEC). No changes to the generator hardware or software are required to operate the BIOK7600. The ChiroSight software runs on a PC workstation and provides the user interface to control the BIOK7600 flat panel. ChiroSight initiates the taking of X-ray images from the BIOK7600. through the Sensor Driver application. Once an X-ray is taken. Sensor Driver reads it from the flat panel and transfers it to ChiroSight. After it receives an image from the BIOK7600, ChiroSight: Automatically optimizes the image quality Permanently stores the image to its database Displays the image to the user Allows the user to perform image manipulations and to add annotations Allows the user store and transfer the images in DICOM format.
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    K Number
    K190311
    Device Name
    BIOK7600 Flat Panel Detector
    Date Cleared
    2019-03-13

    (29 days)

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

    Biokinemetrics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BIOK 7600 is intended for use by a qualified doctor or technologist on both and pediatric patients for taking diagnostic radiographic exposures of all body parts of the patients. The BIOK7600 provides digital image capture and is intended to replace radiographic film/screen. The x-ray generator, x-ray tube and associated equipment are not provided with the proposed sensor. Prescription use only. The BIOK7600 is not intended for mammography.
    Device Description
    The BIOK7600 sensor is a digital radiography sensor which automatically collects x-ray images from an x-ray source. The BIOK7600 sensor (flat panel type) collects x-rays and digitizes the images for their transfer and display to a computer. The sensor does not have an x-ray source, which is provided by independent manufacturers. The sensor includes a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images. An X-ray generator with a minimum voltage output range between 55 to 120 kVp and a minimum power of 30 KW can be used with the BIOK7600. The BIOK7600 does not connect to the generator. It automatically detects x-rays and enables the image acquisition (AEC). No changes to the generator hardware or software are required to operate the BIOK7600. The ChiroSight software runs on a PC workstation and provides the user interface to control the BIOK7600 flat panel. ChiroSight initiates the taking of X-ray images from the BIOK7600, through the Sensor Driver application. Once an X-ray is taken. Sensor Driver reads it from the flat panel and transfers it to ChiroSight. After it receives an image from the BIOK7600, ChiroSight: Automatically optimizes the image quality Permanently stores the image to its database Displays the image to the user Allows the user to perform image manipulations and to add annotations Allows the user store and transfer the images in DICOM format.
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    K Number
    K181565
    Device Name
    Aquarius 8600 Digital Radiography Sensor
    Date Cleared
    2018-07-13

    (29 days)

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

    Biokinemetrics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AQUARIUS 8600 is intended for use by a qualified doctor or technologist on both adult and paediatric patients for taking diagnostic radiographic exposures of all body parts of the AQUARIUS 8600 provides digital image capture and is intended to replace radiographic film/screen. The x-ray tube and associated equipment are not provided with the proposed sensor. Prescription use only. The AQUARIUS 8600 is not intended for mammography.
    Device Description
    The Aquarius 8600 is a digital radiography sensor which automatically collects x-ray images from an x-ray source. The Aquarius 8600 sensor (flat panel type) collects x-rays and digitizes the images for their transfer and display to a computer. The sensor does not have an x-ray source, which is provided by independent manufacturers. The sensor includes with a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images.
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