510(k) · Cleared
CleareduWS-CT
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 Jun 24, 2019 as substantially equivalent to K173001 (Shanghai United Imaging Healthcare Co., Ltd., 2018) after a 220-day review. Its family tree reaches back 12 generations to 1991. 3 of the 187 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.
- Decided
- Jun 24, 2019
- Review
- 220 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K913770 (1991). 182 ancestors in all, the oldest K837107 (1983). 4 later devices descend from it, 3 citing it directly. 3 of the 187 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations between
- 3 generations backK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- 2 generations backK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- 1 generation backK173001 uWS-CTShanghai United Imaging Healthcare Co., Ltd. · 2018
- This deviceK183170 uWS-CTShanghai United Imaging Healthcare Co., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK233209 uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK242624 Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK243632 uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK240411 uAI PortalShanghai United Imaging Intelligence Co., Ltd. · 2024
Show all 12 generations
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 11 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 10 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 9 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 8 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 7 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 6 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 5 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 4 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 3 generations backK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- 2 generations backK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- 1 generation backK173001 uWS-CTShanghai United Imaging Healthcare Co., Ltd. · 2018
- This deviceK183170 uWS-CTShanghai United Imaging Healthcare Co., Ltd. · 2019
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd. · 2024 · cites it directly1descendant
- K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd. · 2025 · 2 generations on0descendants
- K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd. · 2025 · cites it directly0descendants
- K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −11 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −10 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −9 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −8 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −7 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −6 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −5 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −4 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −3 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| −2 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| −1 | K173001 | uWS-CT | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | — |
| 0 (this device) | K183170 | uWS-CT | Shanghai United Imaging Healthcare Co., Ltd. | 2019 | — |
| +1 | K233209 | uOmnispace.CT | Shanghai United Imaging Healthcare Co., Ltd. | 2024 | — |
| +2 | K242624 | Medical Image Post-processing Software (uOmnispace.CT) | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | — |
| +1 | K243632 | uWS-Angio Basic | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | — |
| +1 | K240411 | uAI Portal | Shanghai United Imaging Intelligence Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 9 | 0 |
| 1998 | 12 | 0 |
| 1999 | 6 | 0 |
| 2000 | 11 | 0 |
| 2001 | 17 | 0 |
| 2002 | 13 | 0 |
| 2003 | 8 | 0 |
| 2004 | 15 | 0 |
| 2005 | 11 | 0 |
| 2006 | 10 | 0 |
| 2007 | 8 | 1 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 1 |
| 2011 | 4 | 0 |
| 2012 | 3 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
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.
3 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K173001 | uWS-CTSummary page 5…uct Code: LLZ Regulation Number: 21 CFR 892.2050 Review Panel: Radiology 4. Identification of Predicate Device(s) Predicate Device 510(k) Number: K173001 Device Name: uWS-CT Reference Device#1 510(k) Number: K103480 Device Name: THORACIC VCAR Reference dev… | 2018 |
| † | K103480 | Thoracic Vcar | 2011 |
| † | K033326 | Philips Plus Computed Tomography System | 2003 |
| † | K090546 | Modification to Nordicice Software | 2009 |
| † | K113442 | 3DI | 2012 |
| † | K150843 | syngo®.via (version VB10A) | 2015 |
| † | K120331 | Syngo CT Dynamic Angio | 2012 |
| † | K133643 | Syngo, CT Liver Analysis | 2014 |
| † | K162025 | IntelliSpace Portal Platform | 2016 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 3 generations back · ◆ in the 2012 ancestors bar of FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 5 generations back · ◆ in the 2010 ancestors bar of FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 5 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 43 of the 182 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K233209 (Shanghai United Imaging Healthcare Co., Ltd., 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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-CT is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications: The CT Oncology application is intended to support fast-tracking routine diagnostic oncology, staging, and follow-up, by providing a tool for the user to perform the segmentation and volumetric…
Read the full statement (381 words)
uWS-CT is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:
The CT Oncology application is intended to support fast-tracking routine diagnostic oncology, staging, and follow-up, by providing a tool for the user to perform the segmentation and volumetric evaluation of suspicious lesions in lung or liver.
The CT Colon Analysis application is intended to provide the user a tool to enable easy visualization and efficient evaluation of CT volume data sets of the colon.
The CT Dental application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw.
The CT Lung Nodule application is intended to provide the user a tool for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies.
The CT Vessel Analysis application is intended to provide a tool for viewing, manipulating, and evaluating CT vascular images.
The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.
The CT Lung Density Analysis application is intended to segment pulmonary, lobes, and airway, providing the user quantitative parameters, structure information to evaluate the lung and airway.
The CT Brain Perfusion application is intended to calculate the parameters such as: CBV, CBF, etc. in order to analyze functional blood flow information about a region of interest (ROI) in the brain.
The CT Heart application is intended to segment heart and extract coronary artery. It also provides analysis of vascular stenosis, plaque and heart function.
The CT Calcium Scoring application is intended to identify calcifications and calculate the calcium score.
The CT Dynamic Analysis application is intended to provide visualization of the CT datasets over time with the 3D/4D display modes.
The CT Bone Structure Analysis application is intended to provide visualization and labels for the ribs and spine, and support batch function for intervertebral disk.
The CT Liver Evaluation application is intended to provide processing and visualization for liver segmentation and vessel extraction. It also provides a tool for the user to perform liver separation and residual liver segments evaluation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183170 · printed Nov 3, 2026
Cite this page
510(k) Report. “K183170: uWS-CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K183170
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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