510(k) K041935 ยท LLZ System, Image Processing, Radiological
DR SYSTEMS PACS, RELEASE 6.1
| Applicant | Dr Systems, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Aug 16, 2004 |
| Received | Jul 19, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041935
| 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 |
| Mar 9, 2017 | Merge Healthcare, Inc. DR Systems Unity PACS software, now known as Merge Unity PACS Terminated |
LLZ | None listed |
| Mar 2, 2017 | Merge Healthcare, Inc. DR Systems Unity PACS software, now known as Merge Unity PACS.
Product Usage:
Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printin Terminated |
LLZ | None listed |
| Oct 15, 2015 | Merge Healthcare, Inc. DR Systems Unity PACS software, now known as Merge Unity PACS software. Terminated |
LLZ | None listed |
| Jul 23, 2015 | Merge Healthcare, Inc. Merge Unity Z3D software.
Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, an Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.