510(k) K161109 ยท LLZ System, Image Processing, Radiological
iSR'obot MRI-US Fusion
| Applicant | Biobot Surgical Pte., Ltd., Singapore, SG |
| Decision | Substantially Equivalent, Oct 6, 2016 |
| Received | Apr 20, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161109
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.