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510(k) Data Aggregation

    K Number
    K193238
    Device Name
    Nexus DR Digital X-Ray Imaging System (with vSharp)
    Manufacturer
    Varex Imaging Corporation
    Date Cleared
    2019-12-20

    (25 days)

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

    Varex Imaging Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Varex Nexus DR Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The Nexus DR Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hard-copy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The major system components include an image receptor, computer, monitor and imaging software. The Varex Nexus DR Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).
    Device Description
    The Nexus DR™ Digital X-ray Imaging System (with vSharp™) is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. Nexus DR™ Digital Xray Imaging System (with vSharp™) is designed to support general radiographic (excluding fluoroscopy, angiography, and mammography) procedures through a single common imaging platform. The modified device consists of an X-ray imaging receptor, computer, monitor, and the digital imaging software and the optional vSharp software. The Nexus DR™ Digital X-ray Imaging System (with vSharp™) is a configurable product platform designed to allow Varex to leverage the common components of digital X-ray imaging systems from which the following medical modalities can be served: General Radiography (excluding fluoroscopy, angiography, and mammography). Nexus DR™ Digital X-ray Imaging System (with vSharp™) is then configured to function on a computer with modality specific components, functionality and capabilities to complete the specific product package. Like the predicate device, the modified Nexus DR™ Digital X-ray Imaging System (with vSharp™) is in a class of devices that all use similar technology to acquire digital radiographic images. These devices convert X-rays into visible light that shines onto a TFT array, which converts the visible light into a digital electronic signal. This process is ultimately used for the same purpose as Radiographic film, to create an X-ray image. Identical to the predicate device, the modified device is capable of interfacing with flat panel detectors in v Trigger Mode or RAD Mode utilizing an external I/O box to interface with compatible X-ray generators, in non-integrated mode. The modified device also retains the ability to apply the grid suppression feature. Similar to the already cleared Nexus DR™ Digital X-ray Imaging System with Integrated Generator the modified device, Nexus DR™ Digital X-ray Imaging System (with vSharp™), has the same intended use for the DR application. The modified device, however, adds vSharp™ scatter correction algorithm into the Nexus DR Software, the image contrast is enhanced and the images produced have similar detail contrast as images acquired with an anti-scatter grid. The Nexus DR Digital X-ray Imaging System can then store the images on the local computer, archive them to CD/DVD media, transfer them to Hard Copy format via DICOM printers, or transfer them to PACS reviewing stations in DICOM format.
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    K Number
    K190146
    Device Name
    Nexus DR Digital X-ray Imaging System
    Manufacturer
    Varex Imaging Corporation
    Date Cleared
    2019-03-08

    (38 days)

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

    Varex Imaging Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Varex Nexus DR Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The Nexus DR Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hard-copy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The major system components include an image receptor, computer, monitor and imaging software. The Varex Nexus DR Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).
    Device Description
    The Varex Nexus DR. Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The Nexus DR. Digital X-ray Imaging System is designed to support general radiographic (excluding fluoroscopy, angiography, and mammography) procedures through a single common imaging platform. The modified device consists of an X-ray imaging receptor, computer, monitor, and the digital imaging software and the optional Integrated Generator GUI software. The Varex Nexus DR. Digital X-ray Imaging System is a configurable product platform designed to allow Varex to leverage the common components of digital X-ray imaging systems from which the following medical modalities can be served: General Radiography (excluding fluoroscopy, angiography, and mammography). The Nexus DR. Digital X-ray Imaging System is then configured to function on a computer with modality specific components, functionality and capabilities to complete the specific product package. Like the predicate device, the modified Nexus DR. Digital X-ray Imaging System is in a class of devices that all use similar technology to acquire digital radiographic images. These devices convert X-rays into visible light that shines onto a TFT array, which converts the visible light into a digital electronic signal. This process is ultimately used for the same purpose as Radiographic film, to create an X-ray image. Identical to the predicate device, the modified device is capable of interfacing with flat panel detectors in RAD Mode without utilizing an external I/O box to interface with the X-ray generator. The modified device also retains the ability to apply the grid suppression feature. Similar to the already cleared Nexus DR™ Digital X-ray Imaging System with Stitching and CPI Rad Vision the modified device, Nexus DR™ Digital X-ray Imaging System (with Integrated Generator), has the same intended use for the DR application. The modified device, however, has the ability to allow the operator to control the CPI CMP200 X-ray generator through the Nexus DR™ Graphical User Interface (GUI). All control functions currently available to the operator on the CPI Membrane Rad Console will be available via the Nexus DR GUI. The Nexus DR Digital X-ray Imaging System can then store the images on the local computer, archive them to CD/DVD media, transfer them to Hard Copy format via DICOM printers, or transfer them to PACS reviewing stations in DICOM format.
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    K Number
    K183212
    Device Name
    Nexus DR Digital X-ray Imaging System with stitching
    Manufacturer
    Varex Imaging Corporation
    Date Cleared
    2018-12-07

    (18 days)

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

    Varex Imaging Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Varex Nexus DR Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The Nexus DR Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The major system components include an image receptor, computer, monitor and imaging software. The Varex Nexus DR Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).
    Device Description
    The Varex DRTM Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The DR-m Digital X-ray Imaging System is designed to support general radiographic (excluding fluoroscopy, angiography, and mammography) procedures through a single common imaging platform. The modified device consists of an X-ray imaging receptor, computer, monitor, and the digital imaging software and the optional Stitching software. The Varex DR™ Digital X-ray Imaging System is a configurable product platform designed to allow Varex to leverage the common components of digital X-ray imaging systems from which the following medical modalities can be served: General Radiography (excluding fluoroscopy, angiography, and mammography). The DR™ Digital X-ray Imaging System is then configured to function on a computer with modality specific components, functionality and capabilities to complete the specific product package. Like the predicate device, the modified DR™ Digital X-ray Imaging System is in a class of devices that all use similar technology to acquire digital radiographic images. These devices convert X-rays into visible light that shines onto a TFT array, which converts the visible light into a digital electronic signal. This process is ultimately used for the same purpose as Radiographic film, to create an X-ray image. Identical to the predicate device, the modified device is capable of interfacing with flat panel detectors in vTrigger Mode or RAD Mode utilizing an external I/O box to interface with compatible X-ray generators, in non-integrated mode. The modified device also retains the ability to apply the grid suppression feature. However, the modified device allows the operator to generate sequential radiographic images and electronically join them to create a single electronic image (a leg from hip to foot, for example). Stitching is a post-processing feature that allows the user to merge up to four (4) DICOM images and does not alter the original images. Using a digital flat panel detector, and a non-integrated generator, the Nexus DR Digital X-ray Imaging System (with Stitching) is capable of acquiring multiple digital radiographic images, processing and then displaying them in a high quality single image format to visualize long bones or other anatomical features such as the spine. The Nexus DR Digital X-ray Imaging System can then store the images on the local computer, archive them to CD/DVD media, transfer them to Hard Copy format via DICOM printers, or transfer them to PACS reviewing stations in DICOM format.
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    K Number
    K181526
    Device Name
    XRpad2 4343 HWC-M Flat Panel Detector
    Manufacturer
    Varex Imaging Corporation
    Date Cleared
    2018-07-03

    (22 days)

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

    Varex Imaging Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XRpad2 4343 HWC-M, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammographic use.
    Device Description
    The XRpad2 4343 HWC-M is a wireless, lightweight, cassette-sized, flat panel X-ray detector for digital radiography. It fits into a conventional table or wall-stand Bucky, just like a film-screen cassette. The X-ray detector consists of an amorphous silicon flat panel with a directly deposited Csl:Tl scintillator and dedicated read-out, scan, and control electronics, all packaged in a carbon-fiber and aluminum enclosure. The outside dimensions of the detector are 460 mm × 460 mm × 15.5 mm, which fits into a standard X-ray cassette Bucky. The detector can be integrated with an X-ray system to enable digital radiography. The XRpad2 4343 HWC-M device, like the predicate, relies on the X-ray Imaging Software Library (XISL), to control the detector from the host computer. The XISL is a C/C++-coded software library that provides parameterized functions to interface the device to a host work station via an IP Network connection. By use of the application programming interface (API) of XISL one can acquire images and configure all use functions of the XRpad2 4343 HWC-M detector.
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    K Number
    K172951
    Device Name
    Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)
    Manufacturer
    Varex Imaging Corporation
    Date Cleared
    2017-10-24

    (28 days)

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

    Varex Imaging Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Varex Nexus DR™ Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The Nexus DR™ Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The major system components include an image receptor, computer, monitor and imaging software. The Varex Nexus DR™ Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).
    Device Description
    The Varex Nexus DR™ Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The Nexus DR™ Digital X-ray Imaging System is designed to support general radiographic (excluding fluoroscopy, angiography, and mammography) procedures through a single common imaging platform. The modified device consists of an X-ray imaging receptor, PaxScan 4343RC or PaxScan 4343Rv3, computer, monitor, and the digital imaging software. The Varex Nexus DR™ Digital X-ray Imaging System is a configurable product platform designed to allow Varex to leverage the common components of digital X-ray imaging systems from which the following medical modalities can be served: General Radiography (excluding fluoroscopy, angiography, and mammography). The Nexus DR™ Digital X-ray Imaging System is then configured to function on a computer with modality specific components, functionality and capabilities to complete the specific product package. Like the predicate device, the modified Nexus DRTM Digital X-ray Imaging System is in a class of devices that all use similar technology to acquire digital radiographic images. These devices convert X-rays into visible light that shines onto a TFT array, which converts the visible light into a digital electronic signal. This process is ultimately used for the same purpose as Radiographic film, to create an X-ray image. Identical to the predicate device, the modified device is capable of interfacing with a PaxScan flat panel detector in vTrigger Mode or RAD Mode utilizing an external I/O box to interface with compatible X-ray generators, in non-integrated mode. The modified device also retains the ability to apply the grid suppression feature. However, the modified device is capable of interfacing with the Varex PaxScan 4343RC and PaxScan 4343Rv3 detectors. The main difference between the additional detector models is mechanical; the PaxScan 4343RC is a cassette-sized portable tethered version whereas the PaxScan 4343v3 is utilized in a fixed configuration. Through the use of a digital flat panel detector, and a non-integrated generator, the Nexus DR™ Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) is capable of acquiring digital radiographic images, processing and then displaying them in high quality for clinical diagnosis. The Nexus DR™ Digital X-ray Imaging System can then store the images on the local computer, archive them to CD/DVD media, transfer them to Hard Copy format via DICOM printers, or transfer them to PACS reviewing stations in DICOM format.
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    K Number
    K171138
    Device Name
    Nexus DR Digital X-ray Imaging System
    Manufacturer
    Varex Imaging Corporation
    Date Cleared
    2017-05-17

    (29 days)

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

    Varex Imaging Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Varex Nexus DR™ Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The Nexus DR™ Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The major system components include an image receptor, computer, monitor and imaging software. The Varex Nexus DR™ Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).
    Device Description
    The Varex Nexus DR™ Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The Nexus DR™ Digital X-ray Imaging System is designed to support general radiographic (excluding fluoroscopy, angiography, and mammography) procedures through a single common imaging platform. The modified device consists of an X-ray imaging receptor. Varian PaxScan 4336Wv4, computer, monitor, and the digital imaging software. The Varex Nexus DR™ Digital X-ray Imaging System is a configurable product platform designed to allow Varex to leverage the common components of digital X-ray imaging systems from which the following medical modalities can be served: General Radiography (excluding fluoroscopy, angiography, and mammography). The Nexus DR™ Digital X-ray Imaging System is then configured to function on a computer with modality specific components, functionality and capabilities to complete the specific product package. Like the predicate device, the modified Nexus DR™ Digital X-ray Imaging System is in a class of devices that all use similar technology to acquire digital radiographic images. These devices convert X-rays into visible light that shines onto a TFT array, which converts the visible light into a digital electronic signal. This process is ultimately used for the same purpose as Radiographic film, to create an X-ray image. Identical to the predicate device, the modified device is capable of interfacing with the same wireless PaxScan 4336Wv4 flat panel detector in vTrigger Mode. However, the modified device is also capable of operating in RAD Mode utilizing an external I/O box to interface with compatible X-ray generators, in non-integrated mode. Through the use of a digital flat panel detector, and a non-integrated generator, the Nexus DR™ Digital X-ray Imaging System (with Grid Suppression) is capable of acquiring digital radiographic images, processing and then displaying them in high quality for clinical diagnosis. The Nexus DR™ Digital X-ray Imaging System can then store the images on the local computer, archive them to CD/DVD media, transfer them to Hard Copy format via DICOM printers, or transfer them to PACS reviewing stations in DICOM format. Anti-scatter grids play an important role for enhancing image quality in radiography by transmitting a majority of primary radiation and selectively rejecting scattered radiation. When anti-scatter grids are utilized by the end user, the modified device includes an additional feature that can detect and suppress the line artifacts caused by these grids.
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