510(k) K112213 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | GE Healthcare, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Sep 1, 2011 |
| Received | Aug 2, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112213
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2013 | GE Healthcare, LLC GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM.
The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fe Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.