510(k) · Cleared
Recalled · Class II · 2020Cios Spin
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 Oct 30, 2018 as substantially equivalent to K132094 (Siemens Medi Cal Solutions, Inc., 2014) and 3 other predicates after a 139-day review. Its family tree reaches back 10 generations to 1980. 10 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 30, 2018
- Review
- 139 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 4
- Predicates
- 4
Its longest line of descent runs back 10 generations to K801623 (1980). 72 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 6 generations between
- 3 generations backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- 2 generations backK123529 Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 1 generation backK163286 ARTIS phenoSiemens Medical Solution USA, Inc. · 2017 · Recalled
- This deviceK181550 Cios SpinSiemens Medical Solutions USA, Inc. · 2018
- Descendant · cites it directly · 9 of its ownK203504 Cios FlowSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- Descendant · cites it directly · 3 of its ownK210054 Cios SpinSiemens Medical Systems USA, Inc. · 2021 · Recalled
- Descendant · cites it directly · 2 of its ownK210309 Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 1 of its ownK223410 Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK210055 Cios AlphaSiemens Medical Solutions USA, Inc. · 2021 · Recalled
Show all 10 generations
- Root · 10 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 9 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 8 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 7 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 6 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 5 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 4 generations backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 3 generations backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- 2 generations backK123529 Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 1 generation backK163286 ARTIS phenoSiemens Medical Solution USA, Inc. · 2017 · Recalled
- This deviceK181550 Cios SpinSiemens Medical Solutions USA, Inc. · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K203504Cios FlowSiemens Medical Solutions USA, Inc. · 2020 · cites it directly9descendants
- K210054Cios SpinSiemens Medical Systems USA, Inc. · 2021 · cites it directly3descendants
- K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. · 2021 · cites it directly2descendants
- K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. · 2022 · 2 generations on1descendant
- K210055Cios AlphaSiemens Medical Solutions USA, Inc. · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −9 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −8 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −7 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −6 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −5 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −4 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| −3 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
| −2 | K123529 | Artis Q and Q.Zen- Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2013 | 31 |
| −1 | K163286 | ARTIS pheno | Siemens Medical Solution USA, Inc. | 2017 | 14 |
| 0 (this device) | K181550 | Cios Spin | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +1 | K203504 | Cios Flow | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
| +1 | K210054 | Cios Spin | Siemens Medical Systems USA, Inc. | 2021 | 1 |
| +1 | K210309 | Cios Select (VA21) Flat Panel | Siemens Medical Solutions USA, Inc. | 2021 | 1 |
| +2 | K223410 | Cios Select (VA21) Flat Panel | Siemens Medical Solutions USA, Inc. | 2022 | — |
| +2 | K210055 | Cios Alpha | Siemens Medical Solutions USA, Inc. | 2021 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 7 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 1 | 0 |
| 1995 | 11 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2004 | 8 | 0 |
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 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? (4)
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 4…roduct Codes: OWB, OXO 4. Legally Marketed Primary Predicate Device Trade Name: Cios Alpha 510(k) Clearance #: K132094 Page 1 of 12 Clearance Date: March 11, 2014 Classificatio… | 2014 |
| * | K163286 | ARTIS phenoSummary page 5…icable issues. Legally Marketed Secondary Predicate Device Trade Name: ARTIS pheno (VE10) 510(k) Clearance #: K163286 Clearance Date: March 9, 2017 Classification Name: Image-Intensified Fluoroscopic X-Ray… | 2017 |
| * | K042793 | Arcadis Ordic (Available with Options 3D and 3D Navigation Interface)Summary page 5…applicable issues. Legally Marketed Secondary Predicate Device Trade Name: Arcadis Orbic (3D) 510(k) Clearance #: K042793 Clearance Date: October 29, 2004 Classification Name: Image-Intensified Fluoroscopic X-Ray… | 2004 |
| * | K051133 | Arcadis AvanticSummary page 6…Page 2 of 12 Legally Marketed Secondary Predicate Device Trade Name: Arcadis Avantic 510(k) Clearance #: K051133 Clearance Date: June 1, 2005 Classification Name: Image-Intensified Fluoroscopic X-Ray… | 2005 |
| † | K170747 | syngo Application Software | 2017 |
| † | K132904 | Ziehm Vision RFD | 2013 |
| † | K161976 | Ziehm Solo FD | 2016 |
What descends from it? (10)
3 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 30, 2020 | Class II | Z-2888-2020 | Device Design | Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU). |
| 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. |
| Apr 20, 2020 | Class II | Z-1959-2020 | Process design | Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 16305 / 80, the unplugging of the main cable can cause… |
| Apr 17, 2020 | Class II | Z-2128-2020 | Device Design | The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an electrical shock if the user or other persons touch the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 38 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 28 of the 72 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. 2018, 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 Spin 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181550 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181550: Cios Spin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181550
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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