510(k) K203551 ยท OWB Interventional Fluoroscopic X-Ray System
Alphenix, INFX-8000V/B, /S, V9.1
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Dec 18, 2020 |
| Received | Dec 4, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K203551
| 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 |
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.