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 Mar 4, 2021 as substantially equivalent to K153232 (Siemens Medical Solutions USA, Inc., 2016) and 1 other predicate after a 29-day review. Its family tree reaches back 9 generations to 1991. 1 later device descends from it.
- Decided
- Mar 4, 2021
- Review
- 29 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K912470 (1991). 21 ancestors in all, the oldest K860913 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK912470 Philips Diagnost 96Philips Medical Systems, Inc. · 1991 · Recalled
- 5 generations between
- 3 generations backK132094 Cios AlphaSiemens Medi Cal Solutions, Inc. · 2014 · Recalled
- 2 generations backK153244 Cios FusionSiemens Medical Solutions USA, Inc. · 2016 · Recalled
- 1 generation backK181767 Cios SelectSiemens Medical Solutions USA, Inc. · 2018
- This deviceK210307 Cios Select (VA21) Image IntensifierSiemens Medical Solutions USA, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK223409 Cios Select (VA21) Image IntensifierSiemens Medical Solutions USA, Inc. · 2022
Show all 9 generations
- Root · 9 generations backK912470 Philips Diagnost 96Philips Medical Systems, Inc. · 1991 · Recalled
- 8 generations backK960266 Siregraph CFSiemens Medical Solutions USA, Inc. · 1996 · Recalled
- 7 generations backK970734 Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic…Siemens Medical Solutions USA, Inc. · 1997
- 6 generations backK992660 Urf Digital - OTSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 5 generations backK040675 Axiom Artis USiemens Medical Systems, Inc. · 2004 · Recalled
- 4 generations backK051133 Arcadis AvanticSiemens Medical Solutions USA, Inc. · 2005
- 3 generations backK132094 Cios AlphaSiemens Medi Cal Solutions, Inc. · 2014 · Recalled
- 2 generations backK153244 Cios FusionSiemens Medical Solutions USA, Inc. · 2016 · Recalled
- 1 generation backK181767 Cios SelectSiemens Medical Solutions USA, Inc. · 2018
- This deviceK210307 Cios Select (VA21) Image IntensifierSiemens Medical Solutions USA, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K223409Cios Select (VA21) Image IntensifierSiemens Medical Solutions USA, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K912470 | Philips Diagnost 96 | Philips Medical Systems, Inc. | 1991 | 9 |
| −8 | K960266 | Siregraph CF | Siemens Medical Solutions USA, Inc. | 1996 | 3 |
| −7 | K970734 | Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray Systems | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −6 | K992660 | Urf Digital - OT | Siemens Medical Solutions USA, Inc. | 1999 | 4 |
| −5 | K040675 | Axiom Artis U | Siemens Medical Systems, Inc. | 2004 | 1 |
| −4 | K051133 | Arcadis Avantic | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −3 | K132094 | Cios Alpha | Siemens Medi Cal Solutions, Inc. | 2014 | 8 |
| −2 | K153244 | Cios Fusion | Siemens Medical Solutions USA, Inc. | 2016 | 1 |
| −1 | K181767 | Cios Select | Siemens Medical Solutions USA, Inc. | 2018 | — |
| 0 (this device) | K210307 | Cios Select (VA21) Image Intensifier | Siemens Medical Solutions USA, Inc. | 2021 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K153232 | Cios SelectSummary page 4…OWB, OXO, JAA 4. Legally Marketed Primary Predicate Device Trade Name: Cios Select 510(k) Clearance K153232 Clearance Date February 10, 2016 Classification Name: Image-Intensified Fluoroscopic X-Ray Sys… | 2016 |
| * | K181767 | Cios SelectSummary page 5…nts for this cleared device. Legally Marketed Secondary Predicate Device Trade Name: Cios Select 510(k) Clearance K181767 Clearance Date August 17, 2018 Classification Name: Image-Intensified Fluoroscopic X-Ray Sys… | 2018 |
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 |
|---|---|---|---|
| K223409 | Cios Select (VA21) Image Intensifier | 2022 | 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 30 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 14 of the 21 ancestors have a recall of any class.
- Of its descendants, K223409 (Siemens Medical Solutions USA, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K153232.
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. 2021, 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, and Pulsed Fluoroscopy and
Cassette exposure which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct
display, fluoroscopic display of a 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/K210307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210307: 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/K210307
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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