(256 days)
Not Found
Not Found
No
The summary describes a standard PACS system with image viewing and management functionalities. There is no mention of AI or ML in the intended use, device description, or any other section.
No.
The device is a Picture Archiving and Communication (PACS) software system that stores, distributes, and displays medical images. It does not provide any therapy or treatment.
Yes
The document states, "It provides a diagnostic viewer of medical images for referral purposes," indicating that a component of the system is used for diagnostic viewing.
Yes
The device description explicitly states that Senyint PACS is a "software system" and describes various software components (server applications, Client Image View Workstation, Web-Viewer, Manager Workstation) without mentioning any accompanying hardware that is part of the device itself. It interacts with existing medical imaging modalities and third-party devices, but the PACS system itself is presented as purely software.
Based on the provided information, the Senyint PACS device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Senyint PACS Function: The description clearly states that Senyint PACS is a software system for Picture Archiving and Communication. Its primary function is to receive, store, distribute, and display medical images from various imaging modalities (CT, MRI, etc.). It processes and presents images, but it does not analyze biological specimens.
The device's purpose is centered around managing and viewing medical images, which falls under the category of medical imaging software or a Picture Archiving and Communication System, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
LLZ
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, 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 and a Web-Viewer that is a browser-based web application.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI, CR, OR, 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 PACS 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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle symbol, with three curved lines representing the eagle's body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 13, 2014
Dalian Senyint Digital Medical System Co., Ltd. % Mr. Leon Lu Director of Quality and Regulatory Affairs 3500 South Dupont Highway DOVER DE 19901
Re: K133098
Trade/Device Name: Senyint PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 1, 2014 Received: June 9, 2014
Dear Mr. Lu:
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.
!
1
Page 2-Mr. Lu
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Hsl 2. Nils
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133098
Device Name Senyint PACS
Indications for Use (Describe)
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.
Typical users of Senyint PACS 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Hsl. 2. M̄lds