510(k) K083018 ยท LLZ System, Image Processing, Radiological
CENTRICITY PACS WEB DIAGNOSTIC
| Applicant | Ge Healthcare Dynamic Imaging Solutions, Monroe CT, US |
| Decision | Substantially Equivalent, Nov 14, 2008 |
| Received | Oct 9, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083018
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2017 | Ge Medical Systems Information T Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the syste Terminated |
LLZ | None listed |
| Oct 30, 2013 | Ge Healthcare It Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, comm Terminated |
LLZ | None listed |
| Apr 16, 2010 | Ge Healthcare It GE Centricity Web Diagnostic (WebDX) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
Device that receives, stores and communicates medical images and data from various imaging Terminated |
LLZ | None listed |
| Apr 15, 2010 | Ge Healthcare It GE Centricity Web Diagnostic 1.0(WebDX) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
The Intended use:The Centricity PACS-IW is used to receive medical images (including ma Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.