510(k) · Cleared
Recalled · Class II · 2026uCT 780 with uWS-CT-Dual Energy Analysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai United Imaging Healthcare Co., Ltd. · JAK System, X-Ray, Tomography, Computed
Cleared on Jan 20, 2026 as substantially equivalent to K241079 (Shanghai United Imaging Healthcare Co., Ltd., 2025) after a 116-day review. Its family tree reaches back 17 generations to 2001. It has been recalled once.
- Decided
- Jan 20, 2026
- Review
- 116 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 17 generations to K013561 (2001). 60 ancestors in all, the oldest K930090 (1993). No later device cites it as a predicate yet.
- Root · 17 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 13 generations between
- 3 generations backK211373 SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All…Siemens Medical Solutions USA, Inc. · 2021 · Recalled
- 2 generations backK230162 uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual…Shanghai United Imaging Healthcare Co., Ltd. · 2023 · Recalled
- 1 generation backK241079 uCT 780Shanghai United Imaging Healthcare Co., Ltd. · 2025 · Recalled
- This deviceK253173 uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. · 2026
Show all 17 generations
- Root · 17 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 16 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 15 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
- 14 generations backK052216 Somatom DefinitionSiemens Medical Systems, Inc. · 2005
- 13 generations backK082220 Somatom Flash DSSiemens Medical Solutions USA, Inc. · 2008
- 12 generations backK113342 Somatom Definition FlashSiemens Medical Systems, Inc. · 2011 · Recalled
- 11 generations backK121072 Somatom Definition FlashSiemens Medical Systems, Inc. · 2012 · Recalled
- 10 generations backK133589 Somatom ForceSiemens Medical Solutions USA, Inc. · 2014 · Recalled
- 9 generations backK142955 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge…Siemens Medical Solutions USA, Inc. · 2015 · Recalled
- 8 generations backK161196 SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · Recalled
- 7 generations backK163296 SOMATOM go.Up, SOMATOM go.NowSiemens Medical Solutions USA, Inc. · 2017 · Recalled
- 6 generations backK173632 SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GOSiemens Medical Solutions USA, Inc. · 2018 · Recalled
- 5 generations backK191891 SOMATOM X.citeSiemens Medical Solutions USA, Inc. · 2019
- 4 generations backK200524 SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now…Siemens Medical Solutions USA, Inc. · 2020 · Recalled
- 3 generations backK211373 SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All…Siemens Medical Solutions USA, Inc. · 2021 · Recalled
- 2 generations backK230162 uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual…Shanghai United Imaging Healthcare Co., Ltd. · 2023 · Recalled
- 1 generation backK241079 uCT 780Shanghai United Imaging Healthcare Co., Ltd. · 2025 · Recalled
- This deviceK253173 uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −16 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −15 | K040372 | Lightspeed 7.0 CT Scanner System | Ge Medical Systems, LLC | 2004 | 5 |
| −14 | K052216 | Somatom Definition | Siemens Medical Systems, Inc. | 2005 | — |
| −13 | K082220 | Somatom Flash DS | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −12 | K113342 | Somatom Definition Flash | Siemens Medical Systems, Inc. | 2011 | 1 |
| −11 | K121072 | Somatom Definition Flash | Siemens Medical Systems, Inc. | 2012 | 5 |
| −10 | K133589 | Somatom Force | Siemens Medical Solutions USA, Inc. | 2014 | 9 |
| −9 | K142955 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM… | Siemens Medical Solutions USA, Inc. | 2015 | 16 |
| −8 | K161196 | SOMATOM Drive | Siemens Medical Solutions USA, Inc. | 2016 | 4 |
| −7 | K163296 | SOMATOM go.Up, SOMATOM go.Now | Siemens Medical Solutions USA, Inc. | 2017 | 6 |
| −6 | K173632 | SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO | Siemens Medical Solutions USA, Inc. | 2018 | 18 |
| −5 | K191891 | SOMATOM X.cite | Siemens Medical Solutions USA, Inc. | 2019 | — |
| −4 | K200524 | SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All… | Siemens Medical Solutions USA, Inc. | 2020 | 7 |
| −3 | K211373 | SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM… | Siemens Medical Solutions USA, Inc. | 2021 | 3 |
| −2 | K230162 | uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy… | Shanghai United Imaging Healthcare Co., Ltd. | 2023 | 4 |
| −1 | K241079 | uCT 780 | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | 2 |
| 0 (this device) | K253173 | uCT 780 with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 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.
Planning a device in JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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 |
|---|---|---|---|
| * | K241079 | uCT 780Summary page 5…ystem Regulatory Class: II Product Code: JAK Review Panel: Radiology 4. Identification of Predicate Device(s) Predicate Device 510(k) Number: K241079 Trade Name: uCT 780 with uWS-CT-Dual Energy Analysis Shanghai United Imaging Healthcare Co., Ltd. T e l: +… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 11, 2026 | Class II | Z-3280-2026 | Software design | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 46 of the 60 ancestors have a recall of any class.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
uCT 780 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac and vascular). uCT 780 is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the…
Read the full statement (210 words)
uCT 780 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac and vascular).
uCT 780 is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.
* Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
uWS-CT-Dual Energy Analysis is a post-processing software package that accepts UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253173: uCT 780 with uWS-CT-Dual Energy Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253173
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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