510(k) · Cleared
ClearedSenyint Pacs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dalian Senyint Digital Medical System Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Jun 13, 2014 after a 256-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 13, 2014
- Review
- 256 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
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- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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 that receive images from medical imaging modalities (including but not limited to CT, MRI. CR, OR, MG, US, RE, PET and other…
Read the full statement (360 words)
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 that receive images from medical imaging modalities (including but not limited to CT, MRI. CR, OR, MG, US, RE, PET and other DICOM devices), store and archive them, and distribute 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 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, yE, MIP, MinilP, Alp, tissue segmentation. Batch reconstruction, etc. In addition , using this Workstation, users can edit report and print film.
Senyint 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 Senyint PACS server in a wide area setup. The Web-Viewer has a simple GUI for viewing images including zoom, pan , windlowing, 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 platfonns(e.g. , iPAD, iPhone).
Senyint PACS Manager Workstation is used to set the basic information on the management of the system so that 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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K133098 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133098: Senyint Pacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133098
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026