SENYINT Remote Consultation System

K162727 · Dalian Senyint Digital Medical System Co., Ltd. · LLZ · Feb 8, 2018 · Radiology

Device Facts

• Record ID: K162727
• Device Name: SENYINT Remote Consultation System
• Applicant: Dalian Senyint Digital Medical System Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Feb 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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. Typical users of SENYINT Remote Consultation System are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

Device Story

PACS software system for hospital/clinical environments; receives, archives, and distributes DICOM images from various modalities (CT, MRI, etc.). Includes Client Image View Workstation for 2D/3D image viewing (MPR, VR, MIP, etc.), reporting, and printing; Web-Viewer for remote referral viewing; and management modules for consultation process control and video conferencing. Operated by trained professionals (physicians, radiologists, technicians). Facilitates remote diagnosis and clinical collaboration by providing scalable image access and real-time virtual conferencing. Web-Viewer intended as supplement for referral when primary workstation access is unavailable.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

PACS software system; DICOM-compliant; supports 2D/3D image processing (MPR, VR, MIP, etc.); network-based architecture (server, client workstation, web-viewer); supports video conferencing integration.

Indications for Use

Indicated for use by trained professionals (physicians, radiologists, nurses, technicians) in hospitals and clinical institutions for the storage, retrieval, distribution, viewing, and management of medical images (CT, MRI, CR, DR, MG, US, RF, PET) and remote consultation processes. Not for use on mobile platforms.

Regulatory Classification

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.

Special Controls

*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).

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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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