510(k) K083503 ยท KPR System, X-Ray, Stationary
DRAD30003/RADREX-I
| Applicant | Toshiba America Medical Systems, In.C, Tustin CA, US |
| Decision | Substantially Equivalent, Feb 13, 2009 |
| Received | Nov 26, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083503
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2012 | Toshiba American Medical Systems Inc DRAD-3000E: Radrex-i X-ray is a general purpose X-ray System. Labeling reads in part "TOSHIBA***DIGITAL RADIOGRAPHY SYSTEM RADREX-i DRAD-3000E Systems Data No. MSDXR0144EA***" Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.