510(k) K170909 ยท OWB Interventional Fluoroscopic X-Ray System
Infinix INFX-8000V, V6.40
| Applicant | Toshiba Medical Systems Coroporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Jun 16, 2017 |
| Received | Mar 28, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170909
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2022 | Canon Medical System, USA, INC. INFX-8000V. For radiographic and fluoroscopic studies and intervention. Open, Classified |
OWB | None listed |
| Feb 5, 2021 | Canon Medical System, USA, INC. System INFX-8000V Open, Classified |
OWB | None listed |
| Dec 8, 2020 | Canon Medical System, USA, INC. Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V
Catheterization Table CAT-880B
Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and an Open, Classified |
OWB | None listed |
| Mar 3, 2020 | Canon Medical System, USA, INC. Infinix-8000V 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-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.