510(k) K072365 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Siemens Medical Solutions USA, Inc., Ultrasound DI, Mountainview CA, US |
| Decision | Substantially Equivalent, Oct 17, 2007 |
| Received | Aug 23, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072365
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 5, 2011 | Siemens Medical Solutions USA, Inc. 4Z1c Matrix Array Transducer, model number 10033682, used with ACUSON SC2000 ultrasound systems, model number 10433816, manufactured by Siemens Medical Solutions, Ultrasound Business Unit, Mountain Vi Terminated |
None listed | |
| Dec 28, 2010 | Siemens Medical Solutions USA, Inc. 4Z1c matrix array transducer which is used with ACUSON SC2000 ultrasound system.
Siemens Medical Solutions USA, Inc.
Business Unit Ultrasound
1230 Shorebird Way
Mountain View, CA 94043
Intended use: Terminated |
IYN | None listed |
| Dec 28, 2010 | Siemens Medical Solutions USA, Inc. ACUSON SC 2000 ultrasound system.
Siemens Medical Solutions USA, Inc.
Business Unit Ultrasound
1230 Shorebird Way
Mountain View, CA 94043
Intended use: SC2000 ultrasound system is intended for the f Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.