510(k) K150420 ยท LLZ System, Image Processing, Radiological
Centricity Universal Viewer
| Applicant | GE Healthcare, Barrington IL, US |
| Decision | Substantially Equivalent, May 26, 2015 |
| Received | Feb 18, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150420
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2026 | GE Medical Systems, LLC Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2 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 20, 2023 | GE Healthcare Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System Open, Classified |
LLZ | None listed |
| May 2, 2023 | GE Healthcare Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers:
a) 2088026-003,
b) 2088026-026,
c) 2088026-032,
d) 2088026-043,
e) 2088026-044,
f) 2088026-115,
g) 2088026 Open, Classified |
LLZ | None listed |
| Dec 16, 2022 | GE Medical Systems, LLC Centricity Universal Viewer 6.0.
Used to display medical images (Including mammograms) and data from various imaging sources. 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 |
| Sep 22, 2021 | GE Healthcare, LLC Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. Includes the following Model Numbers Open, Classified |
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 |
| May 17, 2019 | GE Healthcare, LLC Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001
Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammogra Terminated |
LLZ | None listed |
| Dec 20, 2018 | GE Healthcare, LLC GE Healthcare Centricity Universal Viewer Breast Imaging
Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare infor Terminated |
LLZ | None listed |
| Oct 11, 2018 | GE Healthcare, LLC Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources. Terminated |
LLZ | None listed |
| Aug 30, 2018 | GE Healthcare, LLC Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher. Terminated |
LLZ | None listed |
| Jan 25, 2018 | GE Healthcare Centricity 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 sources. Image Terminated |
LLZ | None listed |
| Sep 28, 2015 | GE Healthcare The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed an Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.