510(k) K063803 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Siemens Medical Solutions USA, Inc., Ultrasound DI, Mountain View CA, US |
| Decision | Substantially Equivalent, Jan 5, 2007 |
| Received | Dec 22, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063803
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2011 | Siemens Medical Solutions USA, Inc. Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0. Terminated |
IYN | None listed |
| Mar 28, 2011 | Siemens Medical Solutions USA, Inc., Mountain View, CA ACUSON and SONOLINE Antares and Antares PE ultrasound systems at product versions 4.0 and 5.0 with cardiovascular options installed;
ACUSON Antares 4.0 & 5.0: 10032747, 10037592, 10040728;
ACUSON Ant Terminated |
IYN | None listed |
| Feb 1, 2011 | Siemens Medical Solutions USA, Inc. 10032746 Acuson Antares PE Product Version 5.0, manufactured by Siemens Medical Solutions, Mountain View, CA.
Intended for Abdominal, Intraoperative, Small Parts, Transcranial, OB/Gyn, Cardiac, Trans Terminated |
IYN | None listed |
| Feb 1, 2011 | Siemens Medical Solutions USA, Inc. 10041461 ACUSON S2000, manufactured by Siemens Medical Solutions, Mountain View, CA.
Intended for Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/Gyn, Cardiac, Pelvic, Neon Terminated |
IYO | None listed |
| Feb 1, 2011 | Siemens Medical Solutions USA, Inc. 10430054 Acuson with Physio Module, manufactured by Siemens Medical Solutions, Mountain View, CA. Terminated |
ITX | None listed |
| Sep 2, 2008 | Siemens Medical Solutions USA, Inc. ACUSON Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of the following options installed: 3-Scape Imaging, Factory, PN 05937011 or 3-Scape Real Time Imaging, UPG ACU, Terminated |
IYN | None listed |
| Sep 2, 2008 | Siemens Medical Solutions USA, Inc. Sonoline Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of the following options installed: 3-Scape Imaging, Factory, PN 05937011 or 3-Scape Imaging, Field Upgrade, PN Terminated |
IYO | None listed |
| Jan 9, 2008 | Siemens Medical Solutions USA, Inc. Siemens, ACUSON Antares, Ultrasound System (Standard and Premium Edition), 5.0 Systems with software version 200.0.054, P/N : 10032747 and 10032746 standard, 10032746, 10037591, and 10038202 for prem Terminated |
IYN | None listed |
| Jan 9, 2008 | Siemens Medical Solutions USA, Inc. Siemens, SONOLINE Antares Ultrasound System, 5.0 Systems with software version 200.0.054, P/N 05936518 and 10037593 , Siemens, Ultrasound Division, Mountain View, CA 94039 Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.