510(k) · Cleared
Recalled · Class II · 2026uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS 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 May 16, 2025 as substantially equivalent to K231482 (Shanghai United Imaging Healthcare Co., Ltd., 2023) after a 175-day review. Its family tree reaches back 9 generations to 1993. It has been recalled 3 times.
- Decided
- May 16, 2025
- Review
- 175 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 9 generations to K930090 (1993). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK930090 HelicatElscint, Inc. · 1993
- 5 generations between
- 3 generations backK203448 uCT ATLAS with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. · 2021 · Recalled
- 2 generations backK223028 uCT ATLAS Astound with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. · 2023
- 1 generation backK231482 uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with…Shanghai United Imaging Healthcare Co., Ltd. · 2023 · Recalled
- This deviceK243617 uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with…Shanghai United Imaging Healthcare Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK930090 HelicatElscint, Inc. · 1993
- 8 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 7 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 6 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 5 generations backK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- 4 generations backK172135 uCT Computed Tomography X-ray SystemShanghai United Imaging Healthcare Co., Ltd. · 2018 · Recalled
- 3 generations backK203448 uCT ATLAS with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. · 2021 · Recalled
- 2 generations backK223028 uCT ATLAS Astound with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. · 2023
- 1 generation backK231482 uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with…Shanghai United Imaging Healthcare Co., Ltd. · 2023 · Recalled
- This deviceK243617 uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with…Shanghai United Imaging Healthcare Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −8 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −7 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −6 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −5 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| −4 | K172135 | uCT Computed Tomography X-ray System | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | 7 |
| −3 | K203448 | uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | 2021 | 3 |
| −2 | K223028 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | 2023 | — |
| −1 | K231482 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual… | Shanghai United Imaging Healthcare Co., Ltd. | 2023 | 3 |
| 0 (this device) | K243617 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual… | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | — |
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 |
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 |
|---|---|---|---|
| * | K231482 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy…Summary page 6…4. Identification of Predicate/Reference Device(s) Predicate Device(s) Device Name: uCT ATLAS Astound with uWS-CT-Dual Energy Analysis 510(k) Number: K231482 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiol… | 2023 |
| † | K230162 | uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis | 2023 |
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-3282-2026 | 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-3281-2026 | 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-0221-2026 | Other | Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 7 of the 14 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. 2025, 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 ATLAS Astound is a computed tomography x-ray system, which is intended to produce cross-sectional images of the whole body by computer reconstruction of x-ray transmission data taken at different angles and planes. uCT ATLAS Astound is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography. uCT ATLAS Astound is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent…
Read the full statement (372 words)
uCT ATLAS Astound is a computed tomography x-ray system, which is intended to produce cross-sectional images of the whole body by computer reconstruction of x-ray transmission data taken at different angles and planes. uCT ATLAS Astound is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography.
uCT ATLAS Astound 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.
uCT ATLAS is a computed tomography x-ray system, which is intended to produce cross-sectional images of the whole body by computer reconstruction of x-ray transmission data taken at different angles and planes. uCT ATLAS is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography.
uCT ATLAS has the capability to image a whole organ in a single rotation. Organs include, but not limited to head, heart, liver, kidney, pancreas, joints, etc.
uCT ATLAS 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/K243617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243617: uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS 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/K243617
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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