510(k) K082318 ยท LLZ System, Image Processing, Radiological
CENTRICITY PACS IW
| Applicant | Ge Healthcare Dynamic Imaging Solutions, Monroe CT, US |
| Decision | Substantially Equivalent, Aug 25, 2008 |
| Received | Aug 13, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082318
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2023 | GE Healthcare Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System Open, Classified |
LLZ | None listed |
| May 2, 2023 | GE Healthcare Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012, f) 2049587-015, g) 2052829-001, h) Not applicable;
Radiological Image Processi Open, Classified |
LLZ | None listed |
| May 22, 2019 | GE Healthcare, LLC GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers:
a) 2052831-00x
b) 2050578-0xx
c) 2090228-002
d) 2052782-00x Terminated |
LLZ | None listed |
| Feb 23, 2018 | GE Healthcare GE Healthcare Centricity PACS-IW, Model Numbers:
(a) 2052831-00X
(b) 2049588-008
Product Usage:
Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and Terminated |
LLZ | None listed |
| Oct 5, 2015 | GE Healthcare Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, comm Terminated |
LLZ | None listed |
| Apr 16, 2010 | Ge Healthcare It GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
Device that receives, stores and communicates medical images and data from various imaging sources. Terminated |
LLZ | None listed |
| Apr 15, 2010 | Ge Healthcare It GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
The intended use:The Centricity PACS-IW is used to receive medical images (including mammograms) and data Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.