510(k) K081621 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
INFX-8000C (INFINIX CC-I AND VC-I)
| Applicant | Toshiba America Medical Systems, In.C, Tustin CA, US |
| Decision | Substantially Equivalent, Jun 23, 2008 |
| Received | Jun 9, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081621
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.