K252099
- 510(k) number
- K252099
- Device name
- Trinias
- Applicant
- Shimadzu Corporation JP
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2026-03-24
- Date received
- 2025-07-03
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K252099.pdf
Official FDA record: K252099
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.