(256 days)
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.
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.
This document is a 510(k) premarket notification from the FDA for a Picture Archiving and Communication System (PACS) called "Senyint PACS." It primarily grants market clearance and describes the system's intended use and features. It does not contain information about acceptance criteria, device performance tables, sample sizes for testing or training, expert qualifications, ground truth establishment, or clinical study methodologies.
Therefore, I cannot fulfill your request for this specific document. The information you're asking for would typically be found in a separate clinical study report or a more detailed technical submission to the FDA.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).