510(k) K072676 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
ACUSON X300 ULTRASOUND SYSTEM
| Applicant | Siemens Medical Solutions USA, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Dec 18, 2007 |
| Received | Sep 21, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072676
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2011 | Siemens Medical Solutions USA, Inc. Siemens ACUSON X300 Systems with software versions 3.0.00 and 3.0.02, model numbers 10348531, 10348532 and 10348533, manufactured by Siemens Medical Solutions, Mountain View, CA.
Intended for General Terminated |
IYO | None listed |
| Apr 25, 2011 | Siemens Medical Solutions USA, Inc. Siemens ACUSON X300 Premium Edition Systems with software versions 5.0.00 and 5.0.01 (model numbers 10348531, 10348532 and 10348533), when using the V5Ms transducer (model number 08263703) and the Plu Terminated |
IYO | None listed |
| Apr 25, 2011 | Siemens Medical Solutions USA, Inc. Acuson X300 systems at software versions 1.00.00 to 1.0.10 and 2.0.00 to 2.0.02, model numbers 10037409, 10132987, and 10038837, manufactured by Siemens Medical Solutions ultrasound business unit, Mou Terminated |
IYN | None listed |
| Mar 28, 2011 | Siemens Medical Solutions USA, Inc., Mountain View, CA ACUSON X300, X300 PE and SONOVISTA X300 (all versions) with cardiovascular options installed;
ACUSON X300: 10037409, 10132987, 10038837;
SONOVISTA X300: 10133170;
ACUSON X300 PE: 10348531, 10348532, 1 Terminated |
ITX | None listed |
| Oct 10, 2008 | Siemens Medical Solutions USA, Inc. Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions 2.0.1 to 2.0.05, 3.0.01 and 3.0.02, manufactured by Siemens Ultrasound Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.