510(k) · Cleared
CleareduDR Aurora CX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai United Imaging Healthcare Co., Ltd. · KPR System, X-Ray, Stationary
Cleared on Sep 19, 2025 as substantially equivalent to K241068 (Shanghai United Imaging Healthcare Co., Ltd., 2024) after a 157-day review. Its family tree reaches back 9 generations to 1998.
- Decided
- Sep 19, 2025
- Review
- 157 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K981556 (1998). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 5 generations between
- 3 generations backK133782 Nova FA DR SystemSedecal., Sa. · 2014 · Recalled
- 2 generations backK173953 uDR 780iShanghai United Imaging Healthcare Co., Ltd. · 2018
- 1 generation backK241068 uDR 780iShanghai United Imaging Healthcare Co., Ltd. · 2024
- This deviceK251167 uDR Aurora CXShanghai United Imaging Healthcare Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 8 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 7 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 6 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 5 generations backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- 4 generations backK090279 Sedecal, Millennium PlusSedecal., Sa. · 2009
- 3 generations backK133782 Nova FA DR SystemSedecal., Sa. · 2014 · Recalled
- 2 generations backK173953 uDR 780iShanghai United Imaging Healthcare Co., Ltd. · 2018
- 1 generation backK241068 uDR 780iShanghai United Imaging Healthcare Co., Ltd. · 2024
- This deviceK251167 uDR Aurora CXShanghai 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 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −8 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −7 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −6 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −5 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| −4 | K090279 | Sedecal, Millennium Plus | Sedecal., Sa. | 2009 | — |
| −3 | K133782 | Nova FA DR System | Sedecal., Sa. | 2014 | 1 |
| −2 | K173953 | uDR 780i | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | — |
| −1 | K241068 | uDR 780i | Shanghai United Imaging Healthcare Co., Ltd. | 2024 | — |
| 0 (this device) | K251167 | uDR Aurora CX | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 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 KPR? 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 KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 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 |
|---|---|---|---|
| * | K241068 | uDR 780iSummary page 5…Number: 21 CFR 892. 1680 Review Panel: Radiology 5. Identification of Predicate Device(s) Predicate Device: Trade Name：uDR 780i 510(k) Number: K241068 Classification Name: Stationary X-Ray System Classification Panel: Radiology Regulation Number: 21 CFR 892. 1680… | 2024 |
| † | K213700 | MULTIX Impact, MULTIX Impact C | 2021 |
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 27 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 13 ancestors have a recall of any class.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
uDR Aurora CX is intended to acquire X-ray images of the human body by a qualified technician, examples include acquiring two-dimensional X-ray images of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. The visualization of such anatomical structures provide visual evidence to radiologists and clinicians in making diagnostic decisions. This device is not intended for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251167: uDR Aurora CX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251167
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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