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510(k) Data Aggregation

    K Number
    K132842
    Device Name
    FLAATZ 600 SERIES (FLAATZ 600/601)
    Manufacturer
    DRTECH CORP.
    Date Cleared
    2014-02-21

    (164 days)

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

    DRTECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FLAATZ 600 Series (FLAATZ 600/601) is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).
    Device Description
    The FLAATZ 600 Series (FLAATZ 600/601) is a 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 FLAATZ 600 Series (FLAATZ 600/601) system includes a Detector Panel, Case, Grid, Power Box, Switch Box, Interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a rectangular plate in which the input x-ray photons are absorbed in an a-Se layer. The Power Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Switch Box transfers signals between the Power Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains functions for image data capture and correction of defects on the image data.
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    K Number
    K111655
    Device Name
    FLAATZ 760
    Manufacturer
    DRTECH CORP.
    Date Cleared
    2011-11-30

    (170 days)

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

    DRTECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FLAATZ 760 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).
    Device Description
    The FLAATZ 760 is a 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 FLAATZ 760 system includes a Detector Panel, Control Box, Switch Box, Interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a rectangular plate in which the input x-ray photons are absorbed in an a-Se layer. The Control Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Switch Box transfers signals between the Control Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains functions for image data capture and correction of defects on the image data.
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    K Number
    K111583
    Device Name
    FLAATZ 560
    Manufacturer
    DRTECH CORP.
    Date Cleared
    2011-10-04

    (119 days)

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

    DRTECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FLAATZ 560 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammography applications).
    Device Description
    The FLAATZ 560 is a radiographic image acquisition device. It is a fully integrated image capture and routing system under human operator control. TThis system may be usable by a technician in a typical radiology environment. The FLAATZ 560 system includes a Detector Panel, Case, Grid, Control Box, Switch Box, Interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a rectangular plate in which the input x-ray photons are absorbed in an a-Se layer. The Control Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Switch Box transfers signals between the Control Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains functions for image data capture and correction of defects on the image data.
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    K Number
    K102474
    Device Name
    FLAATZ 750E
    Manufacturer
    DRTECH CORP.
    Date Cleared
    2011-03-04

    (186 days)

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

    DRTECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FLAATZ 750E is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. (excluding fluoroscopic, angiographic, and mammographic applications).
    Device Description
    The FLAATZ 750E is a radlographic image ecquisition 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 FLAATZ 750E system includes a Detector Panel, Control Box, Switch Box, interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an a-Se layer. The Control Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Delector Panel. The Switch Box transfers signals between the Control Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains functions for Image data capture and correction of defects on the image data.
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    K Number
    K091747
    Device Name
    FLAATZ 500
    Manufacturer
    DRTECH CORP.
    Date Cleared
    2009-07-01

    (15 days)

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

    DRTECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FLAATZ 500 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures (excluding fluoroscopic, anglographic, and mammography applications).
    Device Description
    The FLAATZ 500 is a 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 FLAATZ 500 system Includes a Detector Panel, Control Box, Switch Box, Interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an a-Se layer. The Control Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Switch Box transfers signals between the Control Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains for image data capture and correction of defects on the image data.
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    K Number
    K080064
    Device Name
    FLAATZ 750
    Manufacturer
    DRTECH CORP.
    Date Cleared
    2008-01-23

    (13 days)

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

    DRTECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FLAATZ 750 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).
    Device Description
    The FLAATZ 750 is a radiographic image acquisition device. It is a fully integrated image capture and rouling system under human operator control. This system may be useble by a technician in a typical radiology environment. The FLAATZ 750 system includes a Detector Panel, Control Box, Switch Box, Interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an a-Se layer. The Control Box functions as a buffen believe a the Detector Panel and Operating PC while also supplying power to the Detector Panell The Switch Box transfers signals between the Control Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains functions for image data capture and correction of defects on the image data.
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