510(k) K063085 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM
| Applicant | Siemens Medical Solutions USA, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Nov 14, 2006 |
| Received | Oct 10, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063085
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2011 | Siemens Medical Solutions USA, Inc. Auxiliary 2 MHz Continuous Wave (CW) transducer, model number 8251046, when used with ACUSON Sequoia ultrasound systems at SW revision 12.X. Manufactured by Siemens Medical Solutions USA, Inc., Ultra Terminated |
ITX | None listed |
| Sep 11, 2008 | Siemens Medical Solutions USA, Inc. Siemens brand Ultrasound Transducer 17L5HD used with ACUSON Sequoia Ultrasound System;
Model Number(s): 10035724, used with System Models: 08245875, 08246951, 08255412, 08255413, 08267697, 08269627, Terminated |
IYO | None listed |
| Apr 24, 2008 | Siemens Medical Solutions USA, Inc. ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system. Siemens Medical Solutions USA, Inc., Mountain View, CA Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.