510(k) K152697 ยท OWB Interventional Fluoroscopic X-Ray System
INFX-8000C, V6.20
| Applicant | Toshibamedical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Jan 15, 2016 |
| Received | Sep 21, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152697
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2021 | Canon Medical System, USA, INC. System INFX-8000C Open, Classified |
OWB | None listed |
| Dec 8, 2020 | Canon Medical System, USA, INC. Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C
Catheterization Table CAT-880B
Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and ang 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 |
| Mar 3, 2020 | Canon Medical System, USA, INC. Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration Open, Classified |
OWB | None listed |
| Dec 29, 2017 | Toshiba American Medical Systems Inc INFX-8000C Fluoroscopic X-Ray Systems Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.