K253584
- 510(k) number
- K253584
- Device name
- Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
- Applicant
- Canon Medical Systems Corporation JP
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2026-03-10
- Date received
- 2025-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K253584.pdf
Official FDA record: K253584
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.