510(k) K082830 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
INFX-8000H, INFINIX-I
| Applicant | Toshiba America Medical Systems, In.C, Tustin CA, US |
| Decision | Substantially Equivalent, Oct 10, 2008 |
| Received | Sep 26, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082830
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2017 | Toshiba American Medical Systems Inc INFX-8000H Fluoroscopic X-Ray Systems Terminated |
JAA | None listed |
| Dec 1, 2011 | Toshiba American Medical Systems Inc Model CAT-850B Catheterization Table, a component of the Toshiba INFX-8000 series X-Ray Interventional System.
These systems are single or dual plane systems that employ x-rays to obtain fluoroscopy Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.