# K083018: Centricity Pacs Web Diagnostic

- Pathway: 510(k) (Special)
- Applicant: Ge Healthcare Dynamic Imaging Solutions
- Decided: Nov 14, 2008 after 36 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K913770 (1991). 10 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072986: Integradweb Pacs System, GE Healthcare (2007) Summary page 1.
- K043415: Centricity Pacs System, Ge Medical Systems Information Technologies (2005) Summary page 1.

## Most influential descendants
- K112974: Picture Archiving and Communications System (2011), 7 descendants of its own
- K132342: XVWEB (2013), 3 descendants of its own
- K210682: SOTA Cloud Imaging (2021), 1 descendant of its own
- K253111: Aeka Imaging (2026), 0 descendants of its own
- K251880: Archy Dental Imaging (2025), 0 descendants of its own

## Recalls of this device
- Feb 18, 2013 · Class II · Z-1782-2017: It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manual
- Jun 15, 2012 · Class II · Z-0118-2014: Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety risk to patients. These issues include: 1) With Auto-Fetch in use another patient's image may appear with
- Feb 18, 2010 · Not classified · Z-1395-2010: 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-1403-2010: 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 Web Diagnostic (Web DX) PACS System 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, 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/K083018
Methodology: https://510kreport.com/methodology