510(k) K043415 ยท LLZ System, Image Processing, Radiological
CENTRICITY PACS SYSTEM
| Applicant | Ge Medical Systems Information Technologies, Mount Prospect IL, US |
| Decision | Substantially Equivalent, Jan 21, 2005 |
| Received | Dec 13, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043415
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2026 | GE Healthcare Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions Open, Classified |
LLZ | None listed |
| Sep 15, 2026 | GE Healthcare Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions Open, Classified |
LLZ | None listed |
| Sep 15, 2026 | GE Healthcare Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images an Open, Classified |
LLZ | None listed |
| Sep 15, 2026 | GE Healthcare Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions Open, Classified |
LLZ | None listed |
| Sep 15, 2026 | GE Healthcare Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Administration, common configuration management for consuming applic Open, Classified |
LLZ | None listed |
| Sep 15, 2026 | GE Healthcare Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise imaging workflows, All versions Open, Classified |
LLZ | None listed |
| Sep 24, 2024 | GE Healthcare GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system. Open, Classified |
LLZ | None listed |
| Feb 26, 2015 | GE Healthcare The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologis Terminated |
LLZ | None listed |
| May 28, 2014 | GE Healthcare The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professional, including radiologists, physicians, technologist Terminated |
LLZ | None listed |
| Jan 14, 2014 | Ge Healthcare It Centricity PACS System versions 3.X and higher and 4.X and higher
Product Usage: The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by Terminated |
LLZ | None listed |
| Oct 30, 2013 | GE Healthcare It The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologis Terminated |
LLZ | None listed |
| Nov 15, 2012 | GE Healthcare It GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System
Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcar Terminated |
LLZ | None listed |
| Nov 24, 2009 | GE Healthcare Integrated IT Solutions GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
The Centricity PACS is used to receive, stor Terminated |
LLZ | None listed |
| Jul 13, 2009 | GE Healthcare Integrated IT Solutions GE Centricity PACS RA1000 Workstation software (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
The Centricity PACS (Picture Archiving and Communication Terminated |
LLZ | None listed |
| Jul 1, 2009 | GE Healthcare Integrated IT Solutions GE Centricity PACS (Picture Archiving and Communication System) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
The Centricity PACS is used to receive, store, distribute, displ Terminated |
LLZ | None listed |
| Feb 3, 2009 | GE Healthcare Integrated IT Solutions GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
The Centricity PACS (Picture Archiving and Communication System) Wo Terminated |
LLZ | None listed |
| Feb 3, 2009 | GE Healthcare Integrated IT Solutions GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
The Centricity PACS (Picture Archiving and Communication System) Wor Terminated |
LLZ | None listed |
| Jan 27, 2009 | GE Healthcare Integrated IT Solutions GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
The Centricity PACS Workstation is intended for use as a primary d Terminated |
LLZ | None listed |
| Jan 23, 2009 | GE Healthcare Integrated IT Solutions GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
The Centricity PACS Workstation is intended for use as a primary dia Terminated |
LLZ | None listed |
| Dec 13, 2008 | GE Healthcare Integrated IT Solutions GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
The Centricity" PACS Workstation is intended for use as a primary d Terminated |
LLZ | None listed |
| Sep 2, 2008 | GE Healthcare Integrated IT Solutions GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010 Terminated |
LLZ | None listed |
| May 1, 2008 | GE Healthcare Integrated IT Solutions GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010 Terminated |
LLZ | None listed |
| Jan 25, 2007 | GE Healthcare Integrated IT Solutions GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010 Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.