Shield System (Siemens 30x40)— 510(k) K260607
Substantially EquivalentRadiaction , Ltd.
FDA 510(k) clearance K260607 for Shield System (Siemens 30x40), Substantially Equivalent on 2026-07-31. Applicant: Radiaction , Ltd.. Device class: 2.
Summary
Radiaction's Shield System (Siemens 30x40) is filed under OWB, interventional fluoroscopic X-ray systems. The name references Siemens and 30x40, but the record doesn't explain either.
Class II, 21 CFR 892.1650. Radiology is both the classification panel and the review panel, and it came in as a Special 510(k).
Radiaction filed from Tel Aviv, Israel. Review took 157 calendar days (February 24 to July 31, 2026).
Clearance details
- Applicant
- Radiaction , Ltd.
- Product code
- Product code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tel Aviv, IL
Recent devices under product code OWB
view allMore clearances from Radiaction , Ltd.
view allAdverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.