510(k) · Cleared
CleareduWS-Angio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai United Imaging Healthcare Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Sep 12, 2025 as substantially equivalent to K230955 (Siemens Medical Solutions USA, Inc., 2023) after a 247-day review. Its family tree reaches back 12 generations to 2001.
- Decided
- Sep 12, 2025
- Review
- 247 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K010938 (2001). No later device cites it as a predicate yet.
- Root · 12 generations backK010938 Syngo Multimodality WorkstationSiemens Medical Solutions USA, Inc. · 2001 · Recalled
- 8 generations between
- 3 generations backK190780 syngo Application SoftwareSiemens Medical Solution USA, Inc. · 2019
- 2 generations backK220433 syngo Application Software (VE21)Siemens Medical Solution USA, Inc. · 2022
- 1 generation backK230955 syngo Application SoftwareSiemens Medical Solutions USA, Inc. · 2023
- This deviceK250040 uWS-AngioShanghai United Imaging Healthcare Co., Ltd. · 2025
Show all 12 generations
- Root · 12 generations backK010938 Syngo Multimodality WorkstationSiemens Medical Solutions USA, Inc. · 2001 · Recalled
- 11 generations backK040970 LeonardoSiemens Medical Systems, Inc. · 2004 · Recalled
- 10 generations backK042995 X-LeonardoSiemens Medical Solutions USA, Inc. · 2004
- 9 generations backK143319 Syngo X-workplace SW VD10Siemens Medi Cal Solutions, Inc. · 2015 · Recalled
- 8 generations backK153346 syngo Application Software VD11Siemens Medical Solutions USA, Inc. · 2016
- 7 generations backK162541 syngo Application SoftwareSiemens Medical Solutions USA, Inc. · 2016
- 6 generations backK163285 syngo Application SoftwareSiemens Medical Solution USA, Inc. · 2017
- 5 generations backK170747 syngo Application SoftwareSiemens Medical Solutions USA, Inc. · 2017
- 4 generations backK173611 syngo Application SoftwareSiemens Medical Solutions USA, Inc. · 2018
- 3 generations backK190780 syngo Application SoftwareSiemens Medical Solution USA, Inc. · 2019
- 2 generations backK220433 syngo Application Software (VE21)Siemens Medical Solution USA, Inc. · 2022
- 1 generation backK230955 syngo Application SoftwareSiemens Medical Solutions USA, Inc. · 2023
- This deviceK250040 uWS-AngioShanghai United Imaging Healthcare Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K010938 | Syngo Multimodality Workstation | Siemens Medical Solutions USA, Inc. | 2001 | 5 |
| −11 | K040970 | Leonardo | Siemens Medical Systems, Inc. | 2004 | 1 |
| −10 | K042995 | X-Leonardo | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −9 | K143319 | Syngo X-workplace SW VD10 | Siemens Medi Cal Solutions, Inc. | 2015 | 2 |
| −8 | K153346 | syngo Application Software VD11 | Siemens Medical Solutions USA, Inc. | 2016 | — |
| −7 | K162541 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2016 | — |
| −6 | K163285 | syngo Application Software | Siemens Medical Solution USA, Inc. | 2017 | — |
| −5 | K170747 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2017 | — |
| −4 | K173611 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2018 | — |
| −3 | K190780 | syngo Application Software | Siemens Medical Solution USA, Inc. | 2019 | — |
| −2 | K220433 | syngo Application Software (VE21) | Siemens Medical Solution USA, Inc. | 2022 | — |
| −1 | K230955 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2023 | — |
| 0 (this device) | K250040 | uWS-Angio | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K230955 | syngo Application SoftwareSummary page 5…Product Code: LLZ Regulation Number: 21 CFR 892.2050 Review Panel: Radiology 4. Identification of Predicate Device(s) Predicate Device 510(k) Number: K230955 Device Name: Syngo Application Software Regulation Number: 892.2050 Product Code: LLZ… | 2023 |
| † | K131299 | Anythink Pacs Workstation | 2013 |
| † | K233186 | uOmnispace.MR | 2024 |
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.
What does this lineage say?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 12 ancestors have a recall of any class.
- 3 other devices also cite its predicate K230955.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
uWS-Angio is a post-processing software based on the uWS-Angio Basic for viewing, processing, evaluating and analyzing XA images. It has the following application: - The uWS-Angio 2D Vessel Analysis is intended to provide users a tool for quantifying the dimensions of coronary and peripheral vessels from 2D angiographic images. It supports vessel segmentation and output associated diameter parameters and curves. - The uWS-Angio Left Ventricular Analysis…
Read the full statement (162 words)
uWS-Angio is a post-processing software based on the uWS-Angio Basic for viewing, processing, evaluating and analyzing XA images. It has the following application:
- The uWS-Angio 2D Vessel Analysis is intended to provide users a tool for quantifying the dimensions of coronary and peripheral vessels from 2D angiographic images. It supports vessel segmentation and output associated diameter parameters and curves.
- The uWS-Angio Left Ventricular Analysis application is intended to provide users a tool for analyzing left ventricular functions. It supports editing contours of ventricular and outputs a set of parameters to show the ventricular functions and wall motion.
- The uWS-Angio 2D Blood Flow Analysis application is intended to provide users a tool for analyzing blood flow of region of interest in peripheral vessels. It supports adding interest region and output multiple blood flow parameters for further perfusion analysis.
- The uWS-Angio Stitching is intended to provide users a tool for lower extremities stitching bolus-chase acquired images into a stitching image.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250040 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250040: uWS-Angio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250040
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026