510(k) K121916 ยท LLZ System, Image Processing, Radiological
INTUITION
| Applicant | Terarecon,Inc., Foster City CA, US |
| Decision | Substantially Equivalent, Apr 2, 2013 |
| Received | Jul 2, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121916
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2015 | TeraRecon, Inc. Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1:
Picture Archiving and Communications System;
Findings Workflow Modules 4.4.11.82.6784, 4.4.11.116.7134, 4.4.11.144.7589.
A full Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.