(497 days)
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No
The document describes a standard PACS system with image viewing and consultation management features, and there is no mention of AI or ML in the text.
No
The device is a Picture Archiving and Communication System (PACS) software designed for viewing, storing, and distributing medical images, and managing consultation processes. It does not provide any direct therapeutic action to treat or alleviate a disease or condition.
No
The device is a PACS system for archiving, viewing, and distributing medical images. While it provides tools for viewing images and supporting consultation processes, it does not state that it analyzes images or patient data to diagnose conditions or diseases. The "diagnostic viewer" mentioned for the Web-Viewer is for referral purposes and is not intended to replace full workstations, implying it's not for primary diagnostic interpretation.
Yes
The device is explicitly described as a "Picture Archiving and Communication (PACS) software system" and details various software components and functionalities without mentioning any accompanying hardware that is part of the device itself.
Based on the provided information, the SENYINT Remote Consultation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- SENYINT System Function: The SENYINT Remote Consultation System is a PACS software system. Its primary functions are:
- Receiving, storing, archiving, and distributing medical images from imaging modalities (CT, MRI, etc.).
- Providing tools for viewing and manipulating these images (2D and 3D viewing, measurements, etc.).
- Managing consultation processes and facilitating video conferencing for remote consultations.
- System management.
The system deals with medical images, which are generated by imaging modalities that visualize structures within the body. It does not involve the analysis of biological specimens.
Therefore, the SENYINT Remote Consultation System falls under the category of medical imaging software and not In Vitro Diagnostics.
N/A
Intended Use / 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, 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.
Product codes
LLZ
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 to receive images from medical imaging modalities, store and archive them, and distribute them. It also offers a Client Image View Workstation for 2D and 3D viewing, measurements, and reporting, and a Web-Viewer for referral purposes. Additionally, it manages consultation information and processes, and includes a video conference function. A Manager Workstation is used for system management and settings.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI, CR, DR, MG, US, RF, PET and other DICOM devices
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of SENYINT Remote Consultation System are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA acronym and the agency's name are in blue.
Dalian Senyint Digital Medical System Co., Ltd. % Di Wu Regulatory Affairs Consultant Di Wu Regulatory 3440 Indian Queen Lane, Rear PHILADELPHIA PA 19129
Re: K162727
Trade/Device Name: SENYINT Remote Consultation System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 18, 2018 Received: January 19, 2018
Dear Di Wu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
February 8, 2018
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs. Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162727
Device Name SENYINT Remote Consultation System
Indications for Use (Describe)
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.
Typical users of SENYINT Remote Consultation System are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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