510(k) K082628 ยท LLZ System, Image Processing, Radiological
CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23
| Applicant | Circle Cardiovascular Imaging, Inc., Calgary, Alberta, CA |
| Decision | Substantially Equivalent, Nov 20, 2008 |
| Received | Sep 9, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082628
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.