510(k) K052894 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SONOLINE G60 S ULTRASOUND SYSTEM
| Applicant | Siemens Medical Solutions USA, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Nov 23, 2005 |
| Received | Oct 14, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052894
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2008 | Siemens Medical Solutions USA, Inc. Sonoline G50/G60 Ultrasound System, Software versions 1.0.0 to 1.5.0b. The product is a general purpose, mobile software controlled diagnostic ultrasound system. Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.