510(k) K083910 ยท LLZ System, Image Processing, Radiological
VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER
| Applicant | Vidistar, LLC, Greenville SC, US |
| Decision | Substantially Equivalent, Apr 15, 2009 |
| Received | Dec 30, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083910
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2018 | Hitachi Healthcare Americas Corp Informatics Division VidiStar(TM) PACS & DICOM Viewer Software system Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.