510(k) K181185 ยท LLZ System, Image Processing, Radiological
Change Healthcare Enterprise Viewer
| Applicant | Change Healthcare Canada Company, Richmond, CA |
| Decision | Substantially Equivalent, Aug 29, 2018 |
| Received | May 3, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181185
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 19, 2021 | CHANGE HEALTHCARE CANADA COMPANY Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content. Open, Classified |
LLZ | None listed |
| Mar 17, 2021 | CHANGE HEALTHCARE CANADA COMPANY Change Healthcare Enterprise Viewer Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.