510(k) K050240 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM
| Applicant | Siemens Medical Solutions USA, Inc., Issaquah WA, US |
| Decision | Substantially Equivalent, Feb 15, 2005 |
| Received | Feb 2, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050240
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2008 | Siemens Medical Solutions USA, Inc. Acuson CV70 Ultrasound systems Ultrasonic Pulsed echo/doppler imaging system with Software revisions less than 4.0.0b, material number 784539, 7848521, and 7848547.
Is a general purpose, mobile, soft Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.