# K043415: Centricity Pacs System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Jan 21, 2005 after 39 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K913770 (1991). 8 ancestors in all.
324 later devices descend from it; 11 cite it directly.
1 of 333 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023557: Centricity Pacs Plus, GE Medical Systems (2002) Summary page 1.
- K033400: Seno Advantage, Ge Medical Systems W-400 (2003) Summary page 1.

## Most influential descendants
- K071964: Mim 4.1 (Seastar) (2007), 287 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own
- K103576: Mim 5.2 (Brachy) (2011), 79 descendants of its own
- K101749: Syngo Trued Software (2010), 76 descendants of its own
- K101228: Mirada XD (2010), 70 descendants of its own

## Recalls of this device
- Jul 31, 2026 · Class II · Z-3171-2026: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the 
- Jul 31, 2026 · Class II · Z-3166-2026: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the 
- Jul 31, 2026 · Class II · Z-3169-2026: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the 
- Jul 31, 2026 · Class II · Z-3167-2026: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the 
- Jul 31, 2026 · Class II · Z-3170-2026: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the 
- Jul 31, 2026 · Class II · Z-3168-2026: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the 
- Aug 5, 2024 · Class II · Z-3214-2024: GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acq
- Apr 3, 2014 · Class II · Z-1665-2014: It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the Centricity PACS RA1000 workstation and images are rejected from the active displayed stud
- Jun 11, 2013 · Class II · Z-0116-2014: GE has recently become aware of potential issues due to out of context issues associated with specific workflows of the Centricity PACS RA1000 workstation. These issues are as follows: 1) In Centricit
- Feb 18, 2013 · Class II · Z-1214-2015: Using Merge Exam in single Study Mode may result in Missing Study Record (Cannot Display Exam, Send Exam, etc). Exam merge in Single Study Mode may fail on &amp
- Nov 15, 2012 · Class II · Z-2579-2016: While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of the Centricity Exam Manager. When a current and his
- Sep 15, 2012 · Class II · Z-0731-2014: There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam transfer module of Centricity PACS System versions 3.X and higher and 4.X and higher when transferring fro
- Sep 25, 2009 · Not classified · Z-0456-2010: There are potential safety issues, including misdiagnosis or delay in treatment, associated with the use of GE Centricity PACS RA1000 Workstation software that may impact patient safety.
- Apr 3, 2009 · Not classified · Z-1549-2009: There is a potential safety issue associated with the use of GE Centricity PACS software related to configuration of DICOM query retrieval with rejected images.
- Mar 24, 2009 · Not classified · Z-1543-2009: Software anomalies may allow the image orientation to be misinterpreted, posing a potential patient safety issue.
- Jan 12, 2009 · Not classified · Z-0969-2009: If a user site created a custom default display protocol (DDP) to display the current exam versus the historical exam and the user-defined DDP fails, the system displays the exams using a GE default h
- Dec 12, 2008 · Not classified · Z-0836-2009: There is a potential patient safety issue involving the use of the F12 keyboard Approve & Complete function. The issue may cause erroneous information to be added to a report when trying to approve an
- Nov 21, 2008 · Not classified · Z-0928-2009: There is a potential patient safety issue involving patient jacket content, which may result in unintended historical image(s) being displayed.
- Nov 20, 2008 · Not classified · Z-0970-2009: Unread exams may inadvertently get marked as dictated in PACS workstation when the user signs off the report in Talkstation and opens the next exam.
- Sep 25, 2008 · Not classified · Z-0460-2009: Software anomalies result in patient safety issues involving patient jacket content intermittently becoming unintentionally out of synchronization with the images being displayed, and involving Defaul
- May 6, 2008 · Not classified · Z-1826-2008: A software anomaly results in incorrect study date and time information being displayed in the report screen and title, which may result in a potential patient misdiagnosis.
- Dec 28, 2007 · Not classified · Z-1104-2008: Report missing characters: Four special characters, when entered into the exam notes, are not transferred to the preview panel or hard copy printout (greater than [>], less than [<], quotation mark ["
- Jan 12, 2007 · Not classified · Z-0373-2007: The Centricity PACS RA1000 Workstation Software may manifest certain mammography image display problems only if the images were acquired through GE Senographe versions 2000D, DS or Essential.

## Indications for use
The Centricity TM PACS provides scaleable image, data management and storage solutions for medical imaging. The system is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices such as Computed Tomography (CT), Magnetic Resonance (MR), Computed Radiography (CR), Digital X-Ray (DX), Digital Mammography (MG), Ultrasound (US), Nuclear Medicine (NM), Positron Emission Tomography (PET), X-Ray Angiography (XA), and any other DICOM devices. The Centricity TM PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity TM PACS infrastructure. To be viewed for primary interpretation, the digital mammography images must be acquired from an FDA approved Full Field Digital Mammography (FFDM) device for primary interpretation. Furthermore, the FFDM must be able to provide, to the Centricity TM PACS, a viewable DICOM 'for presentation' mammography image as approved by the FDA for primary interpretation. Images that are printed to film must be printed using a FDA approved printer for the diagnosis of digital mammography images. To be viewed for primary diagnosis, digital mammography images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The Web client software allows the user to display and manipulate images stored in the Centricity TM PACS or other DICOM archive device including the Centricity TM Enterprise Archive. The Centricity TM Web is not intended for primary diagnosis. The Centricity TM Infrastructure provides for the system's database management, storage, printing, HL-7 interfacing, and all DICOM services such as Store, Print, Query/ Retrieve, Send, etc. It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application.

Source page: https://510kreport.com/device/K043415
Methodology: https://510kreport.com/methodology