K260607
- 510(k) number
- K260607
- Device name
- Shield System (Siemens 30x40)
- Applicant
- Radiaction , Ltd. IL
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2026-07-31
- Date received
- 2026-02-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K260607.pdf
Official FDA record: K260607
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.