# K082318: Centricity Pacs IW

- Pathway: 510(k) (Special)
- Applicant: Ge Healthcare Dynamic Imaging Solutions
- Decided: Aug 25, 2008 after 12 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K942120 (1994). 11 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031311: Integradweb by Dynamic Imaging, Inc., Dynamic Imaging, Inc. (2003) Summary page 1.
- K042313: Integradweb MPR/Mip, Dynamic Imaging, Inc. (2004) Summary page 1.
- K072986: Integradweb Pacs System, GE Healthcare (2007) Summary page 1.
- K051673: Xeleris 2 Processing and Review Workstation, GE Medical Systems (2005) Summary page 1.

## Most influential descendants
- K121387: Centricity Pacs-IW (2012), 16 descendants of its own
- K123174: Centricity Pacs-IW with Universal Viewer (2012), 15 descendants of its own
- K131977: Centricity Universal Viewer Zero Footprint Client (2013), 6 descendants of its own
- K141881: Rapidresults (2014), 5 descendants of its own
- K222476: OmegaAI Image Viewer (2022), 3 descendants of its own

## Recalls of this device
- Sep 14, 2023 · Class II · Z-0138-2024: GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal View
- Mar 28, 2023 · Class II · Z-1502-2023: GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.
- May 22, 2019 · Class II · Z-1781-2019: There is a potential that one or more image series (i.e., all images within an image set) may be missing from an exam without a warning displayed in the viewer.
- Feb 23, 2018 · Class II · Z-1302-2018: A database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW. There is a potential that one or more image series (i.
- Sep 16, 2015 · Class II · Z-0023-2016: Images may be missing when a system parameter MapRoute is set to a value greater than 1.
- Feb 18, 2010 · Not classified · Z-1394-2010: There is a potential safety issue associated with the use of GE Centricity PACS-IW and PACS Web Diagnostic software related to use of built-in reconstruction functions which may result in incorrect an
- Feb 11, 2010 · Not classified · Z-1402-2010: There is a potential safety issue associated with the use of GE Centricity PACS-IW and PACS Web Diagnostic software when dragging-and-dropping images from the Navigator causing flipping of the images 

## Indications for use
Centricity PACS lW TMby 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, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

Source page: https://510kreport.com/device/K082318
Methodology: https://510kreport.com/methodology