510(k) K161515 ยท LLZ System, Image Processing, Radiological
eUnity
| Applicant | Client Outlook, Inc., Waterloo, CA |
| Decision | Substantially Equivalent, Nov 15, 2016 |
| Received | Jun 2, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161515
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.