510(k) · Cleared
ClearedCios Select (VA21) Image Intensifier
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 6, 2022 as substantially equivalent to K210307 (Siemens Medical Solutions USA, Inc., 2021) after a 27-day review. Its family tree reaches back 10 generations to 1991.
- Decided
- Dec 6, 2022
- Review
- 27 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K912470 (1991). 22 ancestors in all, the oldest K860913 (1986). No later device cites it as a predicate yet.
- Root · 10 generations backK912470 Philips Diagnost 96Philips Medical Systems, Inc. · 1991 · Recalled
- 6 generations between
- 3 generations backK153244 Cios FusionSiemens Medical Solutions USA, Inc. · 2016 · Recalled
- 2 generations backK181767 Cios SelectSiemens Medical Solutions USA, Inc. · 2018
- 1 generation backK210307 Cios Select (VA21) Image IntensifierSiemens Medical Solutions USA, Inc. · 2021
- This deviceK223409 Cios Select (VA21) Image IntensifierSiemens Medical Solutions USA, Inc. · 2022
Show all 10 generations
- Root · 10 generations backK912470 Philips Diagnost 96Philips Medical Systems, Inc. · 1991 · Recalled
- 9 generations backK960266 Siregraph CFSiemens Medical Solutions USA, Inc. · 1996 · Recalled
- 8 generations backK970734 Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic…Siemens Medical Solutions USA, Inc. · 1997
- 7 generations backK992660 Urf Digital - OTSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 6 generations backK040675 Axiom Artis USiemens Medical Systems, Inc. · 2004 · Recalled
- 5 generations backK051133 Arcadis AvanticSiemens Medical Solutions USA, Inc. · 2005
- 4 generations backK132094 Cios AlphaSiemens Medi Cal Solutions, Inc. · 2014 · Recalled
- 3 generations backK153244 Cios FusionSiemens Medical Solutions USA, Inc. · 2016 · Recalled
- 2 generations backK181767 Cios SelectSiemens Medical Solutions USA, Inc. · 2018
- 1 generation backK210307 Cios Select (VA21) Image IntensifierSiemens Medical Solutions USA, Inc. · 2021
- This deviceK223409 Cios Select (VA21) Image IntensifierSiemens Medical Solutions USA, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K912470 | Philips Diagnost 96 | Philips Medical Systems, Inc. | 1991 | 9 |
| −9 | K960266 | Siregraph CF | Siemens Medical Solutions USA, Inc. | 1996 | 3 |
| −8 | K970734 | Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray Systems | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −7 | K992660 | Urf Digital - OT | Siemens Medical Solutions USA, Inc. | 1999 | 4 |
| −6 | K040675 | Axiom Artis U | Siemens Medical Systems, Inc. | 2004 | 1 |
| −5 | K051133 | Arcadis Avantic | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −4 | K132094 | Cios Alpha | Siemens Medi Cal Solutions, Inc. | 2014 | 8 |
| −3 | K153244 | Cios Fusion | Siemens Medical Solutions USA, Inc. | 2016 | 1 |
| −2 | K181767 | Cios Select | Siemens Medical Solutions USA, Inc. | 2018 | — |
| −1 | K210307 | Cios Select (VA21) Image Intensifier | Siemens Medical Solutions USA, Inc. | 2021 | — |
| 0 (this device) | K223409 | Cios Select (VA21) Image Intensifier | 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 |
| 2016 | 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 |
|---|---|---|---|
| * | K210307 | Cios Select (VA21) Image IntensifierSummary page 4…OWB, OXO, JAA 4. Legally Marketed Predicate Device Trade Name: Cios Select (VA21) Image Intensifier 510(k) Clearance K210307 Clearance Date March 4, 2021 Classification Name: Image-intensified fluoroscopic x-ray System… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 14 of the 22 ancestors have a recall of any class.
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 four different modes, Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy and Cassette exposure 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 as stated in the FDA summary.
https://510kreport.com/device/K223409 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223409: Cios Select (VA21) Image Intensifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223409
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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