510(k) K182643 ยท LLZ System, Image Processing, Radiological
IRIS 1.0 System
| Applicant | Intuitive Surgical, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 22, 2019 |
| Received | Sep 24, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182643
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.