510(k) K113052 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
INFINIX-CCI
| Applicant | Toshiba America Medical Systems, In.C, Tustin CA, US |
| Decision | Substantially Equivalent, Nov 22, 2011 |
| Received | Oct 13, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113052
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.