510(k) K082142 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Siemens Medical Solutions USA, Inc., Ultrasound DI, Mountainview CA, US |
| Decision | Substantially Equivalent, Nov 13, 2008 |
| Received | Jul 30, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082142
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2011 | Siemens Medical Solutions USA, Inc. ACUSON S2000 ultrasound system
Manufactured by Siemens Medical Solutions USA, Inc.
Business Unit Ultrasound,
1230 Shorebird Way
Intended for the following applications: Fetal, abdominal, Intraoperati Terminated |
IYN | None listed |
| Apr 6, 2011 | Siemens Medical Solutions USA, Inc. Siemens brand ACUSON S2000 Ultrasound System with software versions:
VA10, VA10A, VA10B, VA10C, VA15; Model Number: 10041461;
Product is manufactured and distributed by Siemens Medical Solutions USA, Terminated |
GKZ | None listed |
| Apr 4, 2011 | Siemens Medical Solutions USA, Inc. TEE Transducer V5M, when used with the Acuson S2000 Ultrasound System, software versions: VA15, VA15A or VA15B; Model Numbers: 10041461 (Acuson S2000) and 8263703 (V5M Transducer);
Product is manufac Terminated |
IYO | None listed |
| Mar 28, 2011 | Siemens Medical Solutions USA, Inc., Mountain View, CA ACUSON S2000 ultrasound systems (all versions) with cardiovascular options installed;
ACUSON S2000: 10041461;
S2000 Cardio Option: 10041853;
Product is manufactured and distributed by
Siemens Medic Terminated |
IYO | None listed |
| Feb 22, 2011 | Siemens Medical Solutions USA, Inc. V5M TEE Transducer, when used with an ACUSON S2000 ultrasound system that has cardiac options installed and is at software version VA10, VA10A, VA10B, VA10C, VA15, VA15A, VA15B, VA16 or VA16A, manufac Terminated |
ITX | 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.