510(k) K153166 ยท LLZ System, Image Processing, Radiological
Fusion Bx
| Applicant | Focal Healtcare, Inc., Toronto, CA |
| Decision | Substantially Equivalent, Jan 25, 2016 |
| Received | Nov 2, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153166
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.