510(k) · Cleared
Recalled · Class II · 2023Cios Flow
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 Dec 22, 2020 as substantially equivalent to K153244 (Siemens Medical Solutions USA, Inc., 2016) and 2 other predicates after a 22-day review. Its family tree reaches back 11 generations to 1980. 9 later devices descend from it. It has been recalled once.
- Decided
- Dec 22, 2020
- Review
- 22 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 11 generations to K801623 (1980). 75 ancestors in all. 9 later devices descend from it, 4 citing it directly.
- Root · 11 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 7 generations between
- 3 generations backK123529 Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 2 generations backK163286 ARTIS phenoSiemens Medical Solution USA, Inc. · 2017 · Recalled
- 1 generation backK181560 Cios AlphaSiemens Medical Systems USA, Inc. · 2018 · Recalled
- This deviceK203504 Cios FlowSiemens Medical Solutions USA, Inc. · 2020
- 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 · cites it directly · 1 of its ownK210055 Cios AlphaSiemens Medical Solutions USA, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK253296 Digital C-ARM with 3DAllengers Medical Systems Limited · 2026
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 backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 4 generations backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- 3 generations backK123529 Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 2 generations backK163286 ARTIS phenoSiemens Medical Solution USA, Inc. · 2017 · Recalled
- 1 generation backK181560 Cios AlphaSiemens Medical Systems USA, Inc. · 2018 · Recalled
- This deviceK203504 Cios FlowSiemens Medical Solutions USA, Inc. · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- 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 · cites it directly1descendant
- K253296Digital C-ARM with 3DAllengers Medical Systems Limited · 2026 · 2 generations on0descendants
View 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 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| −4 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
| −3 | K123529 | Artis Q and Q.Zen- Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2013 | 31 |
| −2 | K163286 | ARTIS pheno | Siemens Medical Solution USA, Inc. | 2017 | 14 |
| −1 | K181560 | Cios Alpha | Siemens Medical Systems USA, Inc. | 2018 | 7 |
| 0 (this device) | K203504 | Cios Flow | Siemens Medical Solutions USA, Inc. | 2020 | — |
| +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 | — |
| +1 | K210055 | Cios Alpha | Siemens Medical Solutions USA, Inc. | 2021 | 1 |
| +2 | K253296 | Digital C-ARM with 3D | Allengers Medical Systems Limited | 2026 | — |
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 | 3 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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…Subsequent Product Code: JAA 4. Legally Marketed Primary Predicate Device Trade Name: Cios Fusion 510(k) Clearance K153244 Clearance Date March 07, 2016 Classification Name: Image-intensified fluoroscopic x-ray System… | 2016 |
| * | K181560 | Cios AlphaSummary page 5…issues. Legally Marketed Secondary Predicate Device Trade Name: Cios Alpha 510(k) Clearance K181560 Clearance Date October 24, 2018 Classification Name: Image-intensified fluoroscopic x-ray System… | 2018 |
| * | K181550 | Cios SpinSummary page 5…issues. Legally Marketed Secondary Predicate Device Trade Name: Cios Spin 510(k) Clearance K181550 Clearance Date October 30, 2018 Classification Name: Image-intensified fluoroscopic x-ray System… | 2018 |
What descends from it? (9)
4 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 |
|---|---|---|---|---|
| Sep 12, 2023 | Class II | Z-0196-2024 | Software design | Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 40 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 31 of the 75 ancestors have a recall of any class.
- Of its descendants, K210054 (Siemens Medical Systems USA, Inc., 2021) has gone furthest, with 3 descendants of its own.
- 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. 2020, 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 Flow 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/K203504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203504: Cios Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203504
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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