# K121387: Centricity Pacs-IW

- Pathway: 510(k) (Special)
- Applicant: Ge Healthcare Integrated IT Solutions
- Decided: Jun 5, 2012 after 28 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K942120 (1994). 12 ancestors in all.
16 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082318: Centricity Pacs IW, Ge Healthcare Dynamic Imaging Solutions (2008) Summary page 1.

## Most influential descendants
- 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
- K150420: Centricity Universal Viewer (2015), 3 descendants of its own

## Recalls of this device
- 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.

## Indications for use
Centricity PACS-IW by GE Healthcare 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 five 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/K121387
Methodology: https://510kreport.com/methodology