510(k) K182546 ยท OWB Interventional Fluoroscopic X-Ray System
Alphenix, INFX-8000H/B, V8.0
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Oct 17, 2018 |
| Received | Sep 17, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182546
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 27, 2026 | Canon Medical System, USA, INC. Alphenix INFX-8000H, interventional fluoroscopic x-ray system 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.