510(k) K061372 ยท LLZ System, Image Processing, Radiological
CENTRICITY AW SUITE OPTION
| Applicant | Ge Healthcare Information Technologies, Barrington IL, US |
| Decision | Substantially Equivalent, May 30, 2006 |
| Received | May 17, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061372
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2008 | GE Healthcare Integrated IT Solutions GE Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus Module; for diagnostic image analysis; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 Terminated |
LLZ | None listed |
| Sep 2, 2008 | GE Healthcare Integrated IT Solutions GE Centricity AW Suite 2.0 Software running on the Centricity RA 1000 or RA600/CA1000 Workstation; for diagnostic image analysis; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.