K251992
- 510(k) number
- K251992
- Device name
- ArmSure Fluoroscopic Positioning System
- Applicant
- Savfe Co. , Ltd. TW
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2026-02-11
- Date received
- 2025-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251992.pdf
Official FDA record: K251992
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.