510(k) K211312 ยท LLZ System, Image Processing, Radiological
Universal Viewer
| Applicant | GE Healthcare, Chicago IL, US |
| Decision | Substantially Equivalent, May 21, 2021 |
| Received | Apr 30, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211312
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2023 | GE Healthcare Universal Viewer Workflow Manager, Image processing radiological system Open, Classified |
LLZ | None listed |
| Aug 24, 2022 | GE Healthcare, LLC (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x. Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.