510(k) K180394 ยท LLZ System, Image Processing, Radiological
BrightMatter Plan 1.6.0
| Applicant | Synaptive Medical, Inc., Toronto, CA |
| Decision | Substantially Equivalent, Mar 9, 2018 |
| Received | Feb 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180394
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.