510(k) K121387 ยท LLZ System, Image Processing, Radiological
CENTRICITY PACS-IW
| Applicant | Ge Healthcare Integrated IT Solutions, Barrington IL, US |
| Decision | Substantially Equivalent, Jun 5, 2012 |
| Received | May 8, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121387
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2015 | GE Healthcare 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.