510(k) · Cleared
CleareduWS-Angio Pro
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 24, 2025 as substantially equivalent to K230955 (Siemens Medical Solutions USA, Inc., 2023) after a 257-day review. Its family tree reaches back 12 generations to 2001.
- Decided
- Sep 24, 2025
- Review
- 257 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 deviceK250045 uWS-Angio ProShanghai 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 deviceK250045 uWS-Angio ProShanghai 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) | K250045 | uWS-Angio Pro | 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 Reference Device#1 510(k) Number: K142273 Device Name: EmboGuide… | 2023 |
| † | K142273 | EmboGuide | 2015 |
| † | K233209 | uOmnispace.CT | 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?
The uWS-Angio Pro is a post-processing software based on the uWS-Angio Basic for viewing, processing, evaluating and analyzing CT, MR, 3D XA images, and overlaying 2D medical images to support image guidance during interventional procedures. It has the following application: The uWS-Angio Pro uTarget view application is intended to provide tools for adding the trajectory to the lesion. It also supports overlay of 3D datasets on 2D fluoroscopy images. The…
Read the full statement (187 words)
The uWS-Angio Pro is a post-processing software based on the uWS-Angio Basic for viewing, processing, evaluating and analyzing CT, MR, 3D XA images, and overlaying 2D medical images to support image guidance during interventional procedures. It has the following application:
The uWS-Angio Pro uTarget view application is intended to provide tools for adding the trajectory to the lesion. It also supports overlay of 3D datasets on 2D fluoroscopy images.
The uWS-Angio Pro uEmbo View application is intended to provide users with tools for planning and guiding interventional procedures. It offers a suite of features to mark targets, detect feeder vessels, and overlay the 3D image with the feeders and the corresponding anatomical X-ray image. When the overlay function is activated, it supports automatic 2D-3D image registration specifically for head neuroimaging, while the manual registration function is not restricted to any specific anatomical region.
The uWS-Angio Pro uCardiac View application is intended to provide users tools to plan and guide the interventional procedures. This application can use CT angiography images for vascular access analysis, aortic root analysis and angle management, and overlay registration display with 2D XA images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250045 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250045: uWS-Angio Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250045
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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