K233107
- 510(k) number
- K233107
- Device name
- Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5
- Applicant
- Canon Medical Systems Corporation JP
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2024-08-30
- Date received
- 2023-09-27
- 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: K233107.pdf
Official FDA record: K233107
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.