510(k) · Cleared
CleareduMC 560i
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai United Imaging Healthcare Co., Ltd. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Dec 19, 2019 as substantially equivalent to K153244 (Siemens Medical Solutions USA, Inc., 2016) after a 401-day review. Its family tree reaches back 8 generations to 1991.
- Decided
- Dec 19, 2019
- Review
- 401 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K912470 (1991). 19 ancestors in all, the oldest K860913 (1986). No later device cites it as a predicate yet.
- Root · 8 generations backK912470 Philips Diagnost 96Philips Medical Systems, Inc. · 1991 · Recalled
- 7 generations backK960266 Siregraph CFSiemens Medical Solutions USA, Inc. · 1996 · Recalled
- 6 generations backK970734 Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic…Siemens Medical Solutions USA, Inc. · 1997
- 5 generations backK992660 Urf Digital - OTSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 4 generations backK040675 Axiom Artis USiemens Medical Systems, Inc. · 2004 · Recalled
- 3 generations backK051133 Arcadis AvanticSiemens Medical Solutions USA, Inc. · 2005
- 2 generations backK132094 Cios AlphaSiemens Medi Cal Solutions, Inc. · 2014 · Recalled
- 1 generation backK153244 Cios FusionSiemens Medical Solutions USA, Inc. · 2016 · Recalled
- This deviceK183144 uMC 560iShanghai United Imaging Healthcare Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K912470 | Philips Diagnost 96 | Philips Medical Systems, Inc. | 1991 | 9 |
| −7 | K960266 | Siregraph CF | Siemens Medical Solutions USA, Inc. | 1996 | 3 |
| −6 | K970734 | Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray Systems | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −5 | K992660 | Urf Digital - OT | Siemens Medical Solutions USA, Inc. | 1999 | 4 |
| −4 | K040675 | Axiom Artis U | Siemens Medical Systems, Inc. | 2004 | 1 |
| −3 | K051133 | Arcadis Avantic | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −2 | K132094 | Cios Alpha | Siemens Medi Cal Solutions, Inc. | 2014 | 8 |
| −1 | K153244 | Cios Fusion | Siemens Medical Solutions USA, Inc. | 2016 | 1 |
| 0 (this device) | K183144 | uMC 560i | Shanghai United Imaging Healthcare Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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 |
|---|---|---|---|
| * | K153244 | Cios FusionSummary page 4…duct Code: OWB, OXO, JAA Regulation Number: 21 CFR 892.1650 Review Panel: Radiology 4. Identification of Predicate Device(s) Predicate Device 510(k) Number: K153244 Device Name: Cios Fusion Manufacturer: Siemens AG Regulatory Information Classification Name: Image-intensified fluor… | 2016 |
| † | K181560 | Cios Alpha | 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 28 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 14 of the 19 ancestors have a recall of any class.
- 3 other devices also cite its predicate K153244.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The uMC 5601 is intended to provide digital imaging of patients during diagnostic and surgical procedures. Examples of clinical application may include, but are not limited to: orthopedic, pain therapy, neurological, pediatric examinations and critical care. The visualization of such anatomical structures assists the clinician with clinical decisions. This device does not support direct radiographic film exposures and is not intended for use in performing mammography.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K183144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183144: uMC 560i.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183144
Report an extraction error
Are you the manufacturer?
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