510(k) K123174 ยท LLZ System, Image Processing, Radiological
CENTRICITY PACS-IW WITH UNIVERSAL VIEWER
| Applicant | GE Healthcare, Barrington IL, US |
| Decision | Substantially Equivalent, Nov 16, 2012 |
| Received | Oct 10, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123174
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2026 | GE Medical Systems, LLC Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-02 Open, Classified |
LLZ | None listed |
| Mar 28, 2025 | GE Healthcare GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers:
1) 2042988-001;
2) 2049587-009;
3) 2049587-011;
4) 2049587-012;
5) 2049587-015;
6) 2049588-012 ;
7) 2052829-001. Open, Classified |
LLZ | None listed |
| Oct 20, 2023 | GE Healthcare Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System Open, Classified |
LLZ | None listed |
| May 2, 2023 | GE Healthcare Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 2066908-111, e) 2066908-123, f) 2066908-136, g) 2066908-150; Radiological Image Pro Open, Classified |
LLZ | None listed |
| Dec 16, 2022 | GE Medical Systems, LLC Centricity PACS-IW with Universal Viewer version 5.0.
Used to display medical images (Including mammograms) and data from various imaging sources. Open, Classified |
LLZ | None listed |
| Sep 22, 2021 | GE Healthcare, LLC Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. Open, Classified |
LLZ | None listed |
| May 17, 2019 | GE Healthcare, LLC Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001
Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sourc Terminated |
LLZ | None listed |
| Oct 11, 2018 | GE Healthcare, LLC Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources. Terminated |
LLZ | None listed |
| Jan 25, 2018 | GE Healthcare Centricity PACS-IW with Universal Viewer
Product Usage:
Usage:
Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging s Terminated |
LLZ | None listed |
| Sep 28, 2015 | GE Healthcare The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, process Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.