510(k) K182415 ยท OWB Interventional Fluoroscopic X-Ray System
Alphenix, INFX-8000F/B, V8.0
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Sep 28, 2018 |
| Received | Sep 4, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182415
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2026 | Canon Medical System, USA, INC. ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM
REF: INFX-8000F 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-8000F, interventional fluoroscopic x-ray system Open, Classified |
OWB | None listed |
| Feb 16, 2024 | Canon Medical System, USA, INC. The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary graphic user interface and a multi-tasking computer enable the sys Open, Classified |
OWB | None listed |
| Dec 20, 2021 | Canon Medical System, USA, INC. Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H. Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.