510(k) · Cleared
Recalled · Class II · 2026uCT Computed Tomography X-ray System
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 Mar 2, 2018 as substantially equivalent to K033326 (Philips Medical Systems, Inc., 2003) after a 231-day review. Its family tree reaches back 5 generations to 1993. 12 later devices descend from it. It has been recalled 7 times.
- Decided
- Mar 2, 2018
- Review
- 231 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 5 generations to K930090 (1993). 10 ancestors in all. 12 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK930090 HelicatElscint, Inc. · 1993
- 4 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 3 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 2 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 1 generation backK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- This deviceK172135 uCT Computed Tomography X-ray SystemShanghai United Imaging Healthcare Co., Ltd. · 2018
- Descendant · cites it directly · 6 of its ownK203448 uCT ATLAS with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. · 2021 · Recalled
- Descendant · cites it directly · 3 of its ownK181414 uCT 530, uCT 550Shanghai United Imaging Healthcare Co., Ltd. · 2018 · Recalled
- Descendant · cites it directly · 2 of its ownK230162 uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual…Shanghai United Imaging Healthcare Co., Ltd. · 2023 · Recalled
- Descendant · 2 generations on · 2 of its ownK223028 uCT ATLAS Astound with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK241079 uCT 780Shanghai United Imaging Healthcare Co., Ltd. · 2025 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K203448uCT ATLAS with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. · 2021 · cites it directly6descendants
- K181414uCT 530, uCT 550Shanghai United Imaging Healthcare Co., Ltd. · 2018 · cites it directly3descendants
- K230162uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. · 2023 · cites it directly2descendants
- K223028uCT ATLAS Astound with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. · 2023 · 2 generations on2descendants
- K241079uCT 780Shanghai United Imaging Healthcare Co., Ltd. · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −4 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −3 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −2 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −1 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| 0 (this device) | K172135 | uCT Computed Tomography X-ray System | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | — |
| +1 | K203448 | uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | 2021 | 3 |
| +1 | K181414 | uCT 530, uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | 10 |
| +1 | K230162 | uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy… | Shanghai United Imaging Healthcare Co., Ltd. | 2023 | 4 |
| +2 | K223028 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | 2023 | — |
| +2 | K241079 | uCT 780 | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K033326 | Philips Plus Computed Tomography SystemSummary page 5…tem Regulatory Class: II Product Code: JAK Review Panel: Radiology 4. Identification of Predicate Device(s) Predicate Device 510(k) Number: K033326 Device Name: “Philips Plus” CT scanner Model(s): Brilliance 40, Brilliance 64 Regulatory Information Regulat… | 2003 |
What descends from it? (12)
See all 125 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-3279-2026 | 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… |
| 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… |
| Sep 12, 2025 | Class II | Z-0219-2026 | Other | Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. |
| Sep 12, 2025 | Class II | Z-0220-2026 | Other | Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. |
| Aug 5, 2020 | Class II | Z-0447-2021 | Software design | A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation. |
| Jun 20, 2020 | Class II | Z-2703-2020 | Device Design | The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. |
| May 8, 2020 | Class II | Z-2522-2020 | Software design | Two issues were identified with the computed tomography x-ray system including an intermittent issue which may affect image data leading to artifacts; and intermittent scout scanning interruption due to occasional angle signal drift. This… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K203448 (Shanghai United Imaging Healthcare Co., Ltd., 2021) has gone furthest, with 6 descendants of its own.
- 8 other devices also cite its predicate K033326.
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. 2018, 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 760/780 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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172135: uCT Computed Tomography X-ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172135
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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