510(k) · Cleared
Recalled · Class II · 2021uDR 592h, uDR 596i
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 Jun 27, 2018 as substantially equivalent to K132934 (Siemens Medi Cal Solutions, Inc., 2014) after a 28-day review. Its family tree reaches back 11 generations to 1980. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 27, 2018
- Review
- 28 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 11 generations to K801623 (1980). 66 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 7 generations between
- 3 generations backK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 2 generations backK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
- 1 generation backK132934 Multix Select DRSiemens Medi Cal Solutions, Inc. · 2014
- This deviceK181413 uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK192293 uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK252000 uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd. · 2025
Show all 11 generations
- Root · 11 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 10 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 9 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 8 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 7 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 6 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 5 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 4 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 3 generations backK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 2 generations backK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
- 1 generation backK132934 Multix Select DRSiemens Medi Cal Solutions, Inc. · 2014
- This deviceK181413 uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −10 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −9 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −8 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −7 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −6 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −5 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −4 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| −3 | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | 11 |
| −2 | K121513 | Multix Fusion | Siemens Medical Solution | 2012 | 4 |
| −1 | K132934 | Multix Select DR | Siemens Medi Cal Solutions, Inc. | 2014 | — |
| 0 (this device) | K181413 | uDR 592h, uDR 596i | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | — |
| +1 | K192293 | uDR 592h, uDR 596i | Shanghai United Imaging Healthcare Co., Ltd. | 2019 | — |
| +2 | K252000 | uDR Arria & uDR Aris | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 13 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 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 |
|---|---|---|---|
| * | K132934 | Multix Select DRSummary page 4…: KPR, MQB Regulation Number: 21 CFR 892. 1680 Review Panel: Radiology 4. Identification of Predicate Device(s) Predicate Device 510(k) Number: K132934 Device Name: Multix Select DR Manufacturer: SIEMENS Regulatory Information Classification Name: Stationary X… | 2014 |
| † | K133693 | Digital Radiography Cxdi-401C Wireless | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192293 | uDR 592h, uDR 596i | 2019 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 25, 2021 | Class II | Z-1160-2021 | Device Design | There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient. |
| Feb 27, 2020 | Class II | Z-2521-2020 | Software design | Two issues were identified with the stationary x-ray system. 1. Some position illustrations in the patient exam interface show the incorrect anatomical position for the standard of care. When the image is acquired with the wrong reference… |
| Jul 30, 2019 | Class II | Z-1075-2022 | Software change control | X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat exposure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 38 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 20 of the 66 ancestors have a recall of any class.
- Of its descendants, K192293 (Shanghai United Imaging Healthcare Co., Ltd., 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
The uDR 592h, uDR596i Radiographic system is intended to use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk .Not for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181413 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181413: uDR 592h, uDR 596i.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181413
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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