# K162727: SENYINT Remote Consultation System

- Pathway: 510(k) (Traditional)
- Applicant: Dalian Senyint Digital Medical System Co., Ltd.
- Decided: Feb 8, 2018 after 497 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for 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, CPR, VR, VE, MIP, MiniIP, 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 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 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 information and consultation process. The consultation information management realizes the input, verification and submission 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 physician 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. Typical users of SENYINT Remote Consultation System are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

Source page: https://510kreport.com/device/K162727
Methodology: https://510kreport.com/methodology