510(k) K233107 ยท OWB Interventional Fluoroscopic X-Ray System
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Aug 30, 2024 |
| Received | Sep 27, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233107
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2026 | Canon Medical System, USA, INC. ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM
REF: INFX-8000V Open, Classified |
OWB | None listed |
| Jan 27, 2026 | Canon Medical System, USA, INC. Alphenix INFX-8000V, interventional fluoroscopic x-ray system Open, Classified |
OWB | None listed |
| Oct 8, 2025 | Canon Medical System, USA, INC. This device is a digital radiography/fluoroscopy system used in a diagnostic
and interventional angiography configuration. The system is indicated for use in diagnostic and
angiographic procedures for Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.