510(k) · Cleared
CleareduCT 520, uCT 528
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shangai United Imaging Healthcare Co., Ltd. · JAK System, X-Ray, Tomography, Computed
Cleared on Jan 3, 2019 as substantially equivalent to K181414 (Shanghai United Imaging Healthcare Co., Ltd., 2018) after a 51-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Jan 3, 2019
- Review
- 51 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K930090 (1993). 12 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK183143 uCT 520, uCT 528Shangai United Imaging Healthcare Co., Ltd. · 2019
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) | 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 |
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 |
|---|---|---|---|
| * | K181414 | uCT 530, uCT 550Summary page 4…tem Regulatory Class: II Product Code: JAK Review Panel: Radiology 4. Identification of Predicate Device(s) Predicate Device 510(k) Number: K181414 Device Name: uCT Computed Tomography X-Ray System Model(s): uCT 530, uCT 550 Regulatory Information Regulati… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 12 ancestors have a recall of any class.
- 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. 2019, 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 520/uCT 528 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/K183143 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183143: uCT 520, uCT 528.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183143
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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