510(k) K181804 ยท OWB Interventional Fluoroscopic X-Ray System
Alphenix, INFX-8000C/B, V8.0
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Aug 2, 2018 |
| Received | Jul 6, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181804
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2022 | Canon Medical System, USA, INC. System: Alphenix 4D CT in combination with CAS-930A (C arm Support)
Model Number:
INFX-8000C/BF,
INFX-8000C/BH,
INFX-8000C/SW 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 |
| Oct 8, 2020 | Canon Medical System, USA, INC. CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and Infinix-8000H - Product Usage: This device is a digital radiogr Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.