510(k) K120073 ยท OWB Interventional Fluoroscopic X-Ray System
INFX-8000V WITH
| Applicant | Toshibamedical Systems Corporation, Tustin CA, US |
| Decision | Substantially Equivalent, Jan 26, 2012 |
| Received | Jan 10, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120073
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2016 | Toshiba American Medical Systems Inc INFX-8000V Bi-Plane X-Ray Interventional System
X-ray systems Terminated |
OWB | None listed |
| Jun 4, 2014 | Toshiba American Medical Systems Inc Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting. Terminated |
MQB | None listed |
| Mar 25, 2013 | Toshiba American Medical Systems Inc Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures. Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.