# K112570: Centricity Cardio Imaging

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare Integrated IT Solutions
- Decided: Nov 30, 2011 after 85 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Centricity* PACS-IW: named in the summary without a submission number
- (no number) Image Arena: named in the summary without a submission number

## Most influential descendants
- K151850: McKesson Cardiology (2015), 2 descendants of its own
- K181080: McKesson Cardiology (2018), 1 descendant of its own
- K212528: Change Healthcare Cardiology (2021), 0 descendants of its own

## Recalls of this device
- Oct 2, 2012 · Class II · Z-0034-2014: GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging product, version 5.0 SP1. Multiple studies may 

## Indications for use
Centricity* Cardio Imaging is a software only Picture Archiving and Communication System (PACS). It will be sold as a software only device to operate on general purpose computing hardware. Centricity* Cardio Imaging receives medical images and other information from various data sources, Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Centricity* Cardio Imaging is intended to assist trained professionals in the viewing, analysis, and diagnostic interpretation of images and other information. These trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses, medical technicians, and assistants.

Source page: https://510kreport.com/device/K112570
Methodology: https://510kreport.com/methodology