510(k) K052884 ยท OWB Interventional Fluoroscopic X-Ray System
MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR
| Applicant | Toshiba America Medical Systems, In.C, Tustin CA, US |
| Decision | Substantially Equivalent, Oct 26, 2005 |
| Received | Oct 13, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052884
| 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 |
| Nov 27, 2007 | Toshiba American Med Sys Inc Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equiped with Digital Radiography System with Software version 3.4er000, Toshiba America Medical Systems, Inc., Tustine, CA 92780 Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.