510(k) K073165 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
DRAD-3000E, RADREX-I
| Applicant | Toshiba America Medical Systems, In.C, Tustin CA, US |
| Decision | Substantially Equivalent, Nov 16, 2007 |
| Received | Nov 9, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073165
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 22, 2010 | Toshiba American Medical Systems Inc Toshiba America Medical Systems Inc (TAMS) Digital Radiography System Radrex-i DRAD-3000E; Electrostatic x-ray imaging system Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.