510(k) K061682 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
GE VOLUSON E8 ULTRASOUND SYSTEM
| Applicant | General Electric Co., Wauwatosa WI, US |
| Decision | Substantially Equivalent, Jul 12, 2006 |
| Received | Jun 15, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061682
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2009 | GE Medical Systems, LLC GE Healthcare Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic Ultrasound Systems Terminated |
IYO | None listed |
| Sep 22, 2008 | GE Healthcare GE Voluson E8 Ultrasound System with software versions 6.0.0, 6.0.1,6.1.0, 6.2.0, 6.2.1, 6.2.2, 6.2,3, 7.0.0, and 7.01.
Intended for use by a qualified physician for ultrasound evaluation of Fetal?O Terminated |
IYO | None listed |
| Nov 7, 2007 | Ge Healthcare GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions; GE Healthcare 9900 West Innovation Drive, Wauwatosa, WI 53226, USA. Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.