510(k) K143318 ยท LLZ System, Image Processing, Radiological
DR Systems Zero Download 3D Viewer (Z3D)
| Applicant | Dr Systems, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Mar 10, 2015 |
| Received | Nov 19, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143318
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2017 | Merge Healthcare, Inc. Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Merge Unity is a medical image and information management system Terminated |
LLZ | None listed |
| Aug 7, 2017 | Merge Healthcare, Inc. Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.