510(k) K122578 ยท LLZ System, Image Processing, Radiological
VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING
| Applicant | Vital Images, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Feb 25, 2013 |
| Received | Aug 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122578
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.