510(k) · Cleared
ClearedCios Select
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 Feb 10, 2016 as substantially equivalent to K963093 (Siemens Medical Solutions USA, Inc., 1996) after a 93-day review. Its family tree reaches back 2 generations to 1991. 6 later devices descend from it.
- Decided
- Feb 10, 2016
- Review
- 93 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K910115 (1991). 5 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK910115 Philips BV-29 Imaging SystemPhilips Medical Systems, Inc. · 1991 · Recalled
- 1 generation backK963093 Siremobil CompactSiemens Medical Solutions USA, Inc. · 1996 · Recalled
- This deviceK153232 Cios SelectSiemens Medical Solutions USA, Inc. · 2016
- Descendant · cites it directly · 5 of its ownK181767 Cios SelectSiemens Medical Solutions USA, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK210309 Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. · 2021 · Recalled
- Descendant · 3 generations on · 1 of its ownK223410 Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK210307 Cios Select (VA21) Image IntensifierSiemens Medical Solutions USA, Inc. · 2021
- Descendant · 4 generations on · 0 of its ownK250241 Cios SelectSiemens Medical Solutions USA, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K181767Cios SelectSiemens Medical Solutions USA, Inc. · 2018 · cites it directly5descendants
- K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. · 2021 · 2 generations on2descendants
- K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. · 2022 · 3 generations on1descendant
- K210307Cios Select (VA21) Image IntensifierSiemens Medical Solutions USA, Inc. · 2021 · cites it directly1descendant
- K250241Cios SelectSiemens Medical Solutions USA, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910115 | Philips BV-29 Imaging System | Philips Medical Systems, Inc. | 1991 | 3 |
| −1 | K963093 | Siremobil Compact | Siemens Medical Solutions USA, Inc. | 1996 | 2 |
| 0 (this device) | K153232 | Cios Select | Siemens Medical Solutions USA, Inc. | 2016 | — |
| +1 | K181767 | Cios Select | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +2 | K210309 | Cios Select (VA21) Flat Panel | Siemens Medical Solutions USA, Inc. | 2021 | 1 |
| +3 | K223410 | Cios Select (VA21) Flat Panel | Siemens Medical Solutions USA, Inc. | 2022 | — |
| +1 | K210307 | Cios Select (VA21) Image Intensifier | Siemens Medical Solutions USA, Inc. | 2021 | — |
| +4 | K250241 | Cios Select | Siemens Medical Solutions USA, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K963093 | Siremobil CompactSummary page 5…Secondary Product Code: JAA 4. Legally Marketed Predicate Device Trade Name: Siremobil Compact 510(k) #: K963093 Clearance Date: September 3, 1996 Classification Name: Image-Intensified Fluoroscopic X-Ray… | 1996 |
What descends from it? (6)
2 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)
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 25 years and passes through 2 companies; a new generation was cleared every 19.4 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K181767 (Siemens Medical Solutions USA, Inc., 2018) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K963093.
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. 2016, 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 Operation room, Traumatology, Endoscopy, Intensive Care Station, Paediatrics, Ambulatory patient care and in Veterinary Medicine. The Cios Select can operate in four ditferent 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 intra-medullary nail implant 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/K153232 · printed Nov 3, 2026
Cite this page
510(k) Report. “K153232: Cios Select.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153232
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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