510(k) K162830 ยท LLZ System, Image Processing, Radiological
SIS Software
| Applicant | Surgical Information Sciences, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Feb 14, 2017 |
| Received | Oct 7, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162830
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.