510(k) K112570 ยท LLZ System, Image Processing, Radiological
CENTRICITY CARDIO IMAGING
| Applicant | Ge Healthcare Integrated IT Solutions, Barrington IL, US |
| Decision | Substantially Equivalent, Nov 30, 2011 |
| Received | Sep 6, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112570
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2013 | GE Healthcare It Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS).
Product Usage: It will be sold as a software only device to operate on general purpose computing Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.