510(k) K043078 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A
| Applicant | Toshiba America Medical Systems, In.C, Tustin CA, US |
| Decision | Substantially Equivalent, Nov 17, 2004 |
| Received | Nov 8, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043078
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2007 | Toshiba American Med Sys Inc NEMIO Ultrasound System, Model SSA-550A , Software versions: V3.1.000B, V3.5.0, V3.5.000A, V3.5.000B, V3.6.0, V3.6.000A, V4.0.0, V4.0.000A, V4.l.0, V4.l.000A, V4.2.0, V4.3.0, V4.5.0, V4.5.000A, Toshi Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.