510(k) · Cleared
Recalled · Class II · 2026uCT 530, uCT 550
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 Aug 14, 2018 as substantially equivalent to K172135 (Shanghai United Imaging Healthcare Co., Ltd., 2018) after a 76-day review. Its family tree reaches back 6 generations to 1993. 3 later devices descend from it. It has been recalled 10 times.
- Decided
- Aug 14, 2018
- Review
- 76 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 10
- Predicates
- 1
Its longest line of descent runs back 6 generations to K930090 (1993). 11 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK930090 HelicatElscint, Inc. · 1993
- 5 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 4 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 3 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 2 generations backK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- 1 generation backK172135 uCT Computed Tomography X-ray SystemShanghai United Imaging Healthcare Co., Ltd. · 2018 · Recalled
- This deviceK181414 uCT 530, uCT 550Shanghai United Imaging Healthcare Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK200016 uCT 530, uCT 550Shanghai United Imaging Healthcare Co., Ltd. · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK241166 uCT 550Shanghai United Imaging Healthcare Co., Ltd. · 2025 · Recalled
- Descendant · cites it directly · 0 of its ownK183143 uCT 520, uCT 528Shangai United Imaging Healthcare Co., Ltd. · 2019
Most influential descendants
Showing 3 of 3 · See all- K200016uCT 530, uCT 550Shanghai United Imaging Healthcare Co., Ltd. · 2020 · cites it directly1descendant
- K241166uCT 550Shanghai United Imaging Healthcare Co., Ltd. · 2025 · 2 generations on0descendants
- K183143uCT 520, uCT 528Shangai United Imaging Healthcare Co., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −5 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −4 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −3 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −2 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| −1 | K172135 | uCT Computed Tomography X-ray System | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | 7 |
| 0 (this device) | K181414 | uCT 530, uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | — |
| +1 | K200016 | uCT 530, uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. | 2020 | 4 |
| +2 | K241166 | uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | 1 |
| +1 | K183143 | uCT 520, uCT 528 | Shangai United Imaging Healthcare Co., Ltd. | 2019 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K172135 | uCT Computed Tomography X-ray SystemSummary page 4…tem Regulatory Class: II Product Code: JAK Review Panel: Radiology 4. Identification of Predicate Device(s) Predicate Device 510(k) Number: K172135 Device Name: uCT Computed Tomography X-Ray System Model(s): uCT 760, uCT 780 Regulatory Information Regulati… | 2018 |
What descends from it? (3)
2 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-3277-2026 | 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-3278-2026 | 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-0217-2026 | 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-0218-2026 | 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-0445-2021 | 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. |
| Aug 5, 2020 | Class II | Z-0446-2021 | 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-2704-2020 | Device Design | The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. |
| Jun 20, 2020 | Class II | Z-2705-2020 | Device Design | The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. |
| May 23, 2020 | Class II | Z-2641-2020 | Software design | Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to… |
| May 8, 2020 | Class II | Z-2472-2020 | Software design | Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to… |
The 5 latest of 10 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.
- 5 of the 11 ancestors have a recall of any class.
- Of its descendants, K200016 (Shanghai United Imaging Healthcare Co., Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K172135.
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?
The uCT Computed Tomography X-ray System uCT 530/550 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, vascular).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181414: uCT 530, uCT 550.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181414
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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