510(k) K181290 ยท LLZ System, Image Processing, Radiological
Fusion Bx 2.0
| Applicant | Focal Healthcare, Inc., Toronto, CA |
| Decision | Substantially Equivalent, Jun 15, 2018 |
| Received | May 16, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181290
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.