510(k) K210900 ยท OWB Interventional Fluoroscopic X-Ray System
Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Apr 12, 2021 |
| Received | Mar 26, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210900
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2026 | Canon Medical System, USA, INC. ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM
REF: INFX-8000C Open, Classified |
OWB | None listed |
| Oct 7, 2026 | Canon Medical System, USA, INC. Alphenix INFX-8000C/B5 Open, Classified |
OWB | None listed |
| Aug 25, 2026 | Canon Medical System, USA, INC. Alphenix Models
INFX-8000C
INFX-8000F
INFX-8000V
This device is a digital radiography/fluoroscopy system used in a diagnostic and
interventional angiography configuration. The system is indicated for Open, Classified |
OWB | None listed |
| Jan 27, 2026 | Canon Medical System, USA, INC. Alphenix INFX-8000C, 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 |
| Feb 16, 2024 | Canon Medical System, USA, INC. The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, be Open, Classified |
OWB | None listed |
| Aug 11, 2023 | Canon Medical System, USA, INC. INFX-8000C XGCP-930AA TABLE SIDE CONSOLE,
INFX-8000C XGCP-930BA TABLE SIDE CONSOLE Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.