510(k) K091295 ยท ITX Transducer, Ultrasonic, Diagnostic
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0
| Applicant | Toshiba America Medical Systems, In.C, Tustin CA, US |
| Decision | Substantially Equivalent, May 15, 2009 |
| Received | May 4, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091295
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2013 | Toshiba American Medical Systems Inc Aplio XG Diagnostic Ultrasound System SSA-790A
Used for routine diagnostic imaging Terminated |
IYN | None listed |
| Aug 10, 2011 | Toshiba American Medical Systems Inc Aplio XG model SSA-790A
Aplio XG (SSA-790A) is a premium-class diagnostic ultrasound system incorporating state-of-the-art technologies. It is provided with the highest level of image quality and op Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.