510(k) K090461 ยท LLZ System, Image Processing, Radiological
IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0
| Applicant | Tomtec Imaging Systems GmbH, Unterschleissheim, DE |
| Decision | Substantially Equivalent, May 22, 2009 |
| Received | Feb 23, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090461
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2012 | Imaging Sciences International, LLC DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3
Radiological Image Processing System Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.