510(k) K121762 ยท LLZ System, Image Processing, Radiological
CARDIAC VX
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Jan 18, 2013 |
| Received | Jun 15, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121762
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2014 | GE Healthcare, LLC GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2.
The GE Cardiac VX for MRI Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.