510(k) · Cleared
ClearedShield System (Siemens 30x40)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiaction, Ltd. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Jul 31, 2026 as substantially equivalent to K222625 (Radiaction, Ltd., 2022) after a 157-day review. Its family tree reaches back 1 generation to 2022.
- Decided
- Jul 31, 2026
- Review
- 157 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K222625 (2022). No later device cites it as a predicate yet.
- Root · 1 generation backK222625 Shield SystemRadiaction, Ltd. · 2022
- This deviceK260607 Shield System (Siemens 30x40)Radiaction, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K222625 | Shield System | Radiaction, Ltd. | 2022 | — |
| 0 (this device) | K260607 | Shield System (Siemens 30x40) | Radiaction, Ltd. | 2026 | — |
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 |
|---|---|---|---|
| * | K222625 | Shield SystemSummary page 5…92.1650 Product Code(s) OowWB | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K222625 Shield System owB Device Description Summary 21 CFR 807.92(a)(4) Radiaction’s Shield System is designed to improve the safety an… | 2022 |
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?
- Its one ancestor has no recall.
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. 2026, 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?
Radiaction’s Shield System is intended for reducing unnecessary exposure to scatter X-ray radiation of medical teams during fluoroscopy-guided-procedures with the Toshiba Infinix-I or Siemens Artis C-arm, by attenuating scatter radiation. It is not intended to be used with such procedures for head and neck areas.
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/K260607 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260607: Shield System (Siemens 30x40).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260607
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026