510(k) K081148 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER
| Applicant | Siemens Medical Solutions USA, Inc., Ultrasound DI, Mountain View CA, US |
| Decision | Substantially Equivalent, Dec 22, 2008 |
| Received | Apr 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081148
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2015 | Siemens Medical Solutions USA, Inc. ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730.
The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding.
The S2000 ABVS ultrasound System for i Terminated |
IYO | None listed |
| Mar 9, 2013 | Siemens Medical Solutions USA, Inc. ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541
Distributed by Siemens Medical Solutions USA Inc.
business Unit: Ultrasound.
The S2000 Automated Breast Volume Scanner (AB Terminated |
IYO | None listed |
| May 6, 2011 | Siemens Medical Solutions USA, Inc. Siemens brand ACUSON S2000, Model 10434730, ABVS ultrasound systems;
Affected sub-components Numbers: (1) 10434968, Boom Welding (for S/Ns 250157, 250162, 250163, 250164, 250166, 250167 and 250169); Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.