510(k) · Cleared
ClearedCios Select (VA21) Flat Panel
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 7, 2022 as substantially equivalent to K210309 (Siemens Medical Solutions USA, Inc., 2021) after a 28-day review. Its family tree reaches back 13 generations to 1980. 1 later device descends from it.
- Decided
- Dec 7, 2022
- Review
- 28 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K801623 (1980). 79 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 9 generations between
- 3 generations backK181560 Cios AlphaSiemens Medical Systems USA, Inc. · 2018 · Recalled
- 2 generations backK203504 Cios FlowSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- 1 generation backK210309 Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. · 2021 · Recalled
- This deviceK223410 Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK250241 Cios SelectSiemens Medical Solutions USA, Inc. · 2025
Show all 13 generations
- Root · 13 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 12 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 11 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 10 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 9 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 8 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 7 generations backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 6 generations backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- 5 generations backK123529 Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 4 generations backK163286 ARTIS phenoSiemens Medical Solution USA, Inc. · 2017 · Recalled
- 3 generations backK181560 Cios AlphaSiemens Medical Systems USA, Inc. · 2018 · Recalled
- 2 generations backK203504 Cios FlowSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- 1 generation backK210309 Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. · 2021 · Recalled
- This deviceK223410 Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K250241Cios SelectSiemens Medical Solutions USA, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −12 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −11 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −10 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −9 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −8 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −7 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| −6 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
| −5 | K123529 | Artis Q and Q.Zen- Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2013 | 31 |
| −4 | K163286 | ARTIS pheno | Siemens Medical Solution USA, Inc. | 2017 | 14 |
| −3 | K181560 | Cios Alpha | Siemens Medical Systems USA, Inc. | 2018 | 7 |
| −2 | K203504 | Cios Flow | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
| −1 | K210309 | Cios Select (VA21) Flat Panel | Siemens Medical Solutions USA, Inc. | 2021 | 1 |
| 0 (this device) | K223410 | Cios Select (VA21) Flat Panel | Siemens Medical Solutions USA, Inc. | 2022 | — |
| +1 | K250241 | Cios Select | Siemens Medical Solutions USA, Inc. | 2025 | — |
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 | 4 | 0 |
| 2018 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K210309 | Cios Select (VA21) Flat PanelSummary page 4…OWB, OXO, JAA 4. Legally Marketed Predicate Device Trade Name: Cios Select (VA21) Flat Panel 510(k) Clearance K210309 Clearance Date March 5, 2021 Classification Name: Image-intensified fluoroscopic x-ray System… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250241 | Cios Select | 2025 | 0 |
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 42 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 33 of the 79 ancestors have a recall of any class.
- Of its descendants, K250241 (Siemens Medical Solutions USA, Inc., 2025) has gone furthest, with 0 descendants of its own.
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. 2022, 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 Select is a mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine.
The Cios Select can operate in three different modes, Digital Radiography, Fluoroscopy, and Pulsed Fluoroscopy which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of an intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.
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/K223410 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223410: Cios Select (VA21) Flat Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223410
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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