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510(k) Data Aggregation

    K Number
    K162727
    Device Name
    SENYINT Remote Consultation System
    Date Cleared
    2018-02-08

    (497 days)

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

    Dalian Senyint Digital Medical System Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SENYINT Remote Consultation System is a Picture Archiving and Communication (PACS) software system. It is a software system including several applications working together whose intended use is to provide completely scalable local and wide area PACS solutions for hospital, related Institutions and sites. SENYINT Remote Consultation System provides several server applications that receive images from medical imaging modalities(including but not limited to CT, MRI, CR, DR, MG, US, RF, PET and other DICOM devices), store and archive them, and distribute them to DICOM devices, 3rd party Image View Workstation, SENYINT Remote Consultation System Web-Viewer, etc. SENYINT Remote Consultation System provides a Client Image View Workstation. It allows the user to access patient records and retrieve images from the PACS server in a network. Senyint Image View Workstation has a simple GUI for viewing images in 2D and 3D mode. The functions in 2D mode including zoom, pan, windowing, basic measurements, image mosaic, cine, etc. It also display images from CT, MR and PET in the 3D mode including MPR, OPR, VR, VE, MIP, MinilP, AIP, tissue segmentation, Batch reconstruction, etc. In addition, using this Workstation, users can edit report and print film. SENYINT Remote Consultation System provides a Web-Viewer that is a browser-based web application. It allows the user to access patient records and retrieve images from the PACS server in a wide area setup. The Web-Viewer has a simple GUI for viewing images including, basic measurements, cine, etc. It provides a diagnostic viewer of medical images for referral purposes. It is not intended to replace full workstations and should be used only when there is no access to a workstation. It is available as a supplement sub-system to SENYINT Remote Consultation System or as a stand-alone Web-based image and information distribution system. It is not intended to be used on mobile device platforms(e.g., iPAD, iPhone) . SENYINT Remote Consultation System can manage the consultation and consultation process. The consultation information management realizes the input, verification of remote consultation information. The consultation process management realizes the quality control and review of consultation nodes and process. The video conference function can be used to build a real-time virtual conference between application and consultation physicians during remote consultation and diagnosis. SENYINT Remote Consultation System Manager Workstation is used to set the basic information on the management of the system so that the system can work normally. The system management achieves the settings of such information as hospital, departments, physicians, user roles and video conference. Only authorized users to be able to visit our Workstation to operate.
    Device Description
    SENYINT Remote Consultation System is a Picture Archiving and Communication (PACS) software system. It is a software system including several applications working together whose intended use is to provide completely scalable local and wide area PACS solutions for hospital, related Institutions and sites. It provides server applications that receive, store, archive, and distribute images from medical imaging modalities. It also provides a Client Image View Workstation for accessing patient records and viewing images in 2D and 3D modes with various functions, and a Web-Viewer for accessing and viewing images for referral purposes. Additionally, it includes functions for managing consultation information and processes, video conferencing, and system management.
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    K Number
    K133098
    Device Name
    SENYINT PACS
    Date Cleared
    2014-06-13

    (256 days)

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

    DALIAN SENYINT DIGITAL MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Senyint PACS is a Picture Archiving and Communication (PACS) software system. It is a software system including several applications working together whose intended use is to provide completely scalable local and wide area PACS solutions for hospital, related Institutions and sites. Senyint PACS provides several server applications thates from medical imaging modalities (including but not limited to CT, MRI, CR, OR, MG, US, RF, PET and other DICOM devices), store and dissribute them to DICOM devices, 3rd party Image View Workstation , Senyint PACS Web-Viewer, etc. Senyint PACS provides a Client Image View Workstation. It allows the user to access patient records and retrieve images from the PACS server in a network. Senyint Image View Workstation has a simple GUI for viewing images in 2D and 3D mode. The finctions in 2D mode including zoom, pan , windowing, basic measurements, image mosaic, cine, etc. It also display images from CT, MR and PET in the 3D mode including MPR, OPR, VR, VE, MIP, MinilP, AIP, tissue segmentation, Batch reconstruction, etc. In addition , using this Workstation, users can edit report and print film. Senvint PACS provides a Web-Viewer that is a browser-based web application. It allows the user to access patient records and retrieve images from the Senyin PACS server in a wide area setup. The Web-Viewer has a simple GUI for viewing inaluding zoom, pan , windowing, basic measurements, cine, etc. It provides a diagnostic viewer of medical images for referral purposes. It is not intended to replace full workstations and should be used only when there is no access to a workstation. It is available as a supplement sub-system to Senyint PACS or as a stand-alone Web-based image and information distribution system. It is not intended to be used on mobile device platforms(e.g. , iPAD, iPhone) . Senyint PACS Manager Workstation is used to set the basic information on the management of the system can work normally. Only authorized users to be able to visit our workstations to operate.
    Device Description
    Senyint PACS is a Picture Archiving and Communication (PACS) software system. It is a software system including several applications working together whose intended use is to provide completely scalable local and wide area PACS solutions for hospital, related Institutions and sites. Senyint PACS provides several server applications thates from medical imaging modalities (including but not limited to CT, MRI, CR, OR, MG, US, RF, PET and other DICOM devices), store and dissribute them to DICOM devices, 3rd party Image View Workstation , Senyint PACS Web-Viewer, etc. Senyint PACS provides a Client Image View Workstation. It allows the user to access patient records and retrieve images from the PACS server in a network. Senyint Image View Workstation has a simple GUI for viewing images in 2D and 3D mode. The finctions in 2D mode including zoom, pan , windowing, basic measurements, image mosaic, cine, etc. It also display images from CT, MR and PET in the 3D mode including MPR, OPR, VR, VE, MIP, MinilP, AIP, tissue segmentation, Batch reconstruction, etc. In addition , using this Workstation, users can edit report and print film. Senvint PACS provides a Web-Viewer that is a browser-based web application. It allows the user to access patient records and retrieve images from the Senyin PACS server in a wide area setup. The Web-Viewer has a simple GUI for viewing inaluding zoom, pan , windowing, basic measurements, cine, etc. It provides a diagnostic viewer of medical images for referral purposes. It is not intended to replace full workstations and should be used only when there is no access to a workstation. It is available as a supplement sub-system to Senyint PACS or as a stand-alone Web-based image and information distribution system. It is not intended to be used on mobile device platforms(e.g. , iPAD, iPhone) . Senyint PACS Manager Workstation is used to set the basic information on the management of the system can work normally. Only authorized users to be able to visit our workstations to operate.
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