510(k) K061605 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
NEMIO XG, SAA-580A
| Applicant | Toshiba America Medical Systems, In.C, Tustin CA, US |
| Decision | Substantially Equivalent, Jun 22, 2006 |
| Received | Jun 9, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061605
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2007 | Toshiba American Med Sys Inc NEMIO XG Ultrasound System, Model SSA-580A , Software versions: VI .5.0, Vl .5.000A, VI .5.000B, V2.0.0,Toshiba America Medical Systems, Inc., Tustin, CA. Terminated |
IYN | None listed |
| May 5, 2007 | Toshiba American Med Sys Inc Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Toshiba American Medical Systems, Inc., Tusin, CA. Terminated |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.