510(k) K182419 ยท LLZ System, Image Processing, Radiological
Centricity Universal Viewer
| Applicant | GE Healthcare, Chicago IL, US |
| Decision | Substantially Equivalent, Dec 14, 2018 |
| Received | Sep 5, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182419
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2026 | GE Medical Systems, LLC Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 58 Open, Classified |
LLZ | None listed |
| Mar 28, 2025 | GE Healthcare GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077;
2) 2066908-136;
3) 2066908-150;
4) 2088026-003;
5) 2088026-026;
6) 2088026-032;
7) 2088026-043;
8) 2088026-110;
9 Open, Classified |
LLZ | None listed |
| Oct 23, 2023 | GE Healthcare Centricity 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 |
| Oct 2, 2021 | GE Healthcare, LLC Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system Terminated |
LLZ | None listed |
| Mar 19, 2021 | GE Healthcare, LLC Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information. Terminated |
LLZ | None listed |
| Jan 17, 2020 | GE Healthcare, LLC Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Terminated |
LLZ | None listed |
| Jul 1, 2019 | GE Healthcare, LLC Centricity Universal Viewer 6.0
Is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.