510(k) K192304 ยท LLZ System, Image Processing, Radiological
SIS Software Version 3.6.0
| Applicant | Surgical Information Sciences, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Sep 13, 2019 |
| Received | Aug 23, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192304
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.