510(k) · Cleared
Recalled · Class II · 2020Cios Alpha
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medi Cal Solutions, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Mar 11, 2014 as substantially equivalent to K051133 (Siemens Medical Solutions USA, Inc., 2005) after a 246-day review. Its family tree reaches back 6 generations to 1991. 19 later devices descend from it. It has been recalled 8 times.
- Decided
- Mar 11, 2014
- Review
- 246 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 6 generations to K912470 (1991). 17 ancestors in all, the oldest K860913 (1986). 19 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK912470 Philips Diagnost 96Philips Medical Systems, Inc. · 1991 · Recalled
- 5 generations backK960266 Siregraph CFSiemens Medical Solutions USA, Inc. · 1996 · Recalled
- 4 generations backK970734 Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic…Siemens Medical Solutions USA, Inc. · 1997
- 3 generations backK992660 Urf Digital - OTSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 2 generations backK040675 Axiom Artis USiemens Medical Systems, Inc. · 2004 · Recalled
- 1 generation backK051133 Arcadis AvanticSiemens Medical Solutions USA, Inc. · 2005
- This deviceK132094 Cios AlphaSiemens Medi Cal Solutions, Inc. · 2014
- Descendant · cites it directly · 15 of its ownK153244 Cios FusionSiemens Medical Solutions USA, Inc. · 2016 · Recalled
- Descendant · cites it directly · 10 of its ownK181550 Cios SpinSiemens Medical Solutions USA, Inc. · 2018 · Recalled
- Descendant · cites it directly · 10 of its ownK181560 Cios AlphaSiemens Medical Systems USA, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 9 of its ownK203504 Cios FlowSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 5 of its ownK181767 Cios SelectSiemens Medical Solutions USA, Inc. · 2018
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K153244Cios FusionSiemens Medical Solutions USA, Inc. · 2016 · cites it directly15descendants
- K181550Cios SpinSiemens Medical Solutions USA, Inc. · 2018 · cites it directly10descendants
- K181560Cios AlphaSiemens Medical Systems USA, Inc. · 2018 · cites it directly10descendants
- K203504Cios FlowSiemens Medical Solutions USA, Inc. · 2020 · 2 generations on9descendants
- K181767Cios SelectSiemens Medical Solutions USA, Inc. · 2018 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K912470 | Philips Diagnost 96 | Philips Medical Systems, Inc. | 1991 | 9 |
| −5 | K960266 | Siregraph CF | Siemens Medical Solutions USA, Inc. | 1996 | 3 |
| −4 | K970734 | Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray Systems | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −3 | K992660 | Urf Digital - OT | Siemens Medical Solutions USA, Inc. | 1999 | 4 |
| −2 | K040675 | Axiom Artis U | Siemens Medical Systems, Inc. | 2004 | 1 |
| −1 | K051133 | Arcadis Avantic | Siemens Medical Solutions USA, Inc. | 2005 | — |
| 0 (this device) | K132094 | Cios Alpha | Siemens Medi Cal Solutions, Inc. | 2014 | — |
| +1 | K153244 | Cios Fusion | Siemens Medical Solutions USA, Inc. | 2016 | 1 |
| +1 | K181550 | Cios Spin | Siemens Medical Solutions USA, Inc. | 2018 | 4 |
| +1 | K181560 | Cios Alpha | Siemens Medical Systems USA, Inc. | 2018 | 7 |
| +2 | K203504 | Cios Flow | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
| +2 | K181767 | Cios Select | Siemens Medical Solutions USA, Inc. | 2018 | — |
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 |
|---|---|---|
| 2016 | 2 | 0 |
| 2018 | 3 | 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? (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 |
|---|---|---|---|
| * | K051133 | Arcadis AvanticSummary page 2…. 7. Substantial Equivalence: The Cios Alpha is substantially equivalent to the commercially available Siemens ARCADIS Avantic, cleared 06/01/2005 with K051133. The Indication for use statement is similar to the predicate. The image intensifier has been replaced by a solid s… | 2005 |
What descends from it? (19)
See all 195 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 |
|---|---|---|---|---|
| Jul 14, 2020 | Class II | Z-2848-2020 | Device Design | Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D80 (below revision 04 installed) of the generator which is part of the main unit (c-arm) and cause permanent loss of imaging functionality. |
| Nov 25, 2019 | Class II | Z-0782-2020 | Nonconforming Material/Component | During a routine inspection of a system, a crack on the C-arm holder was discovered. In the event the C-arm holder has a crack, the stability of the C-arm may be compromised and could lead to deformations of the C-arm. In very unlikely… |
| Jun 20, 2019 | Class II | Z-1953-2019 | Nonconforming Material/Component | DAP chamber may be missing an insulating foil |
| Mar 18, 2019 | Class II | Z-1298-2019 | Device Design | Continuous operation at very high tube output may result in increased wear of the radiation emitting components. This may occur when tube voltages of 125 kV are used for a long period, e.g. 30 minutes or more of continuous use. As a… |
| Feb 19, 2016 | Class II | Z-1278-2016 | Software in the Use Environment | Software issues on Cios Alpha mobile C-Arm system |
| Feb 16, 2016 | Class II | Z-1281-2016 | Nonconforming Material/Component | Siemens found a defective part in their production line which could increase risk of an electrical shock for service personnel when working inside the device during system maintenance. The risk of an electrical shock is only present when… |
| Aug 17, 2015 | Class II | Z-0118-2016 | Device Design | patient procedure interruption due to a potential system failure |
| May 5, 2015 | Class II | Z-1958-2015 | Software design | under certain circumstances the Cios Alpha system may freeze during a procedure. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 12 of the 17 ancestors have a recall of any class.
- Of its descendants, K153244 (Siemens Medical Solutions USA, Inc., 2016) has gone furthest, with 15 descendants of its own.
- 2 other devices also cite its predicate K051133.
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. 2014, 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 Alpha 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, gastro-intestinal, 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/K132094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132094: Cios Alpha.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132094
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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