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 Feb 25, 2020 as substantially equivalent to K181414 (Shanghai United Imaging Healthcare Co., Ltd., 2018) and 1 other predicate after a 53-day review. Its family tree reaches back 7 generations to 1993. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Feb 25, 2020
- Review
- 53 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 7 generations to K930090 (1993). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK930090 HelicatElscint, Inc. · 1993
- 6 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 5 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 4 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 3 generations backK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- 2 generations backK172135 uCT Computed Tomography X-ray SystemShanghai United Imaging Healthcare Co., Ltd. · 2018 · Recalled
- 1 generation backK181414 uCT 530, uCT 550Shanghai United Imaging Healthcare Co., Ltd. · 2018 · Recalled
- This deviceK200016 uCT 530, uCT 550Shanghai United Imaging Healthcare Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK241166 uCT 550Shanghai United Imaging Healthcare Co., Ltd. · 2025 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K241166uCT 550Shanghai United Imaging Healthcare Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −6 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −5 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −4 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −3 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| −2 | K172135 | uCT Computed Tomography X-ray System | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | 7 |
| −1 | K181414 | uCT 530, uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | 10 |
| 0 (this device) | K200016 | uCT 530, uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. | 2020 | — |
| +1 | K241166 | uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | 1 |
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 |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K181414 | uCT 530, uCT 550Summary page 4…Regulatory Class: II Product Code: JAK Review Panel: Radiology 4. Identification of Predicate Device(s) Primary Predicate Device: 510(k) Number: K181414 Device Name: uCT Computed Tomography X-Ray System Model(s): uCT 530, uCT 550 Regulatory Information Regulati… | 2018 |
| * | K172135 | uCT Computed Tomography X-ray SystemSummary page 4…me: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology Secondary Predicate Device: 510(k) Number: K172135 Device Name: uCT Computed Tomography X-Ray System Model(s): uCT 760, uCT 780… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241166 | uCT 550 | 2025 | 0 |
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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 12 ancestors have a recall of any class.
- Of its descendants, K241166 (Shanghai United Imaging Healthcare Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K181414.
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. 2020, 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 uCT530/550 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, cardiac (calcium scoring) and vascular.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200016: 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/K200016
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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