K251602
- 510(k) number
- K251602
- Device name
- Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
- Applicant
- Canon Medical Systems Corporation JP
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2025-10-10
- Date received
- 2025-05-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251602.pdf
Official FDA record: K251602
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.