510(k) · Cleared
Recalled · Class II · 2019Cios Fusion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Mar 7, 2016 as substantially equivalent to K132094 (Siemens Medi Cal Solutions, Inc., 2014) and 1 other predicate after a 119-day review. Its family tree reaches back 7 generations to 1991. 15 later devices descend from it. It has been recalled once.
- Decided
- Mar 7, 2016
- Review
- 119 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 7 generations to K912470 (1991). 18 ancestors in all, the oldest K860913 (1986). 15 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK912470 Philips Diagnost 96Philips Medical Systems, Inc. · 1991 · Recalled
- 6 generations backK960266 Siregraph CFSiemens Medical Solutions USA, Inc. · 1996 · Recalled
- 5 generations backK970734 Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic…Siemens Medical Solutions USA, Inc. · 1997
- 4 generations backK992660 Urf Digital - OTSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 3 generations backK040675 Axiom Artis USiemens Medical Systems, Inc. · 2004 · Recalled
- 2 generations backK051133 Arcadis AvanticSiemens Medical Solutions USA, Inc. · 2005
- 1 generation backK132094 Cios AlphaSiemens Medi Cal Solutions, Inc. · 2014 · Recalled
- This deviceK153244 Cios FusionSiemens Medical Solutions USA, Inc. · 2016
- Descendant · cites it directly · 9 of its ownK203504 Cios FlowSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- Descendant · cites it directly · 5 of its ownK181767 Cios SelectSiemens Medical Solutions USA, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK210054 Cios SpinSiemens Medical Systems USA, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 2 of its ownK210309 Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. · 2021 · Recalled
- Descendant · 3 generations on · 1 of its ownK223410 Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. · 2022
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K203504Cios FlowSiemens Medical Solutions USA, Inc. · 2020 · cites it directly9descendants
- K181767Cios SelectSiemens Medical Solutions USA, Inc. · 2018 · cites it directly5descendants
- K210054Cios SpinSiemens Medical Systems USA, Inc. · 2021 · 2 generations on3descendants
- K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. · 2021 · 2 generations on2descendants
- K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K912470 | Philips Diagnost 96 | Philips Medical Systems, Inc. | 1991 | 9 |
| −6 | K960266 | Siregraph CF | Siemens Medical Solutions USA, Inc. | 1996 | 3 |
| −5 | K970734 | Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray Systems | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −4 | K992660 | Urf Digital - OT | Siemens Medical Solutions USA, Inc. | 1999 | 4 |
| −3 | K040675 | Axiom Artis U | Siemens Medical Systems, Inc. | 2004 | 1 |
| −2 | K051133 | Arcadis Avantic | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −1 | K132094 | Cios Alpha | Siemens Medi Cal Solutions, Inc. | 2014 | 8 |
| 0 (this device) | K153244 | Cios Fusion | Siemens Medical Solutions USA, Inc. | 2016 | — |
| +1 | K203504 | Cios Flow | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
| +1 | K181767 | Cios Select | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +2 | K210054 | Cios Spin | Siemens Medical Systems USA, Inc. | 2021 | 1 |
| +2 | K210309 | Cios Select (VA21) Flat Panel | Siemens Medical Solutions USA, Inc. | 2021 | 1 |
| +3 | K223410 | Cios Select (VA21) Flat Panel | Siemens Medical Solutions USA, Inc. | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K132094 | Cios AlphaSummary page 5…2 4. Legally Marketed Predicate Devices: Primary Predicate: Trade Name: Cios Alpha 510(k) Number: K132094 Device: Interventional Fluoroscopic X-Ray system Regulation Medical Specialty: Radiology… | 2014 |
| * | K040066 | Siremobile C06Summary page 5…ation: Z-1958-2015 Secondary Predicate: Trade Name: Siremobil C-06 (renamed: Arcadis Varic) 510(k) Number: K040066 Device: Image-intensified Fluoroscopic X-ray system, Mobile Re… | 2004 |
What descends from it? (15)
See all 154 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 20, 2019 | Class II | Z-1954-2019 | Nonconforming Material/Component | DAP chamber may be missing an insulating foil |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 13 of the 18 ancestors have a recall of any class.
- Of its descendants, K203504 (Siemens Medical Solutions USA, Inc., 2020) has gone furthest, with 9 descendants of its own.
- 4 other devices also cite its predicate K132094.
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. 2016, 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 Cios Fusion is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastrointestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153244: Cios Fusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153244
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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