# K112096: Imagelink

- Pathway: 510(k) (Abbreviated)
- Applicant: Computer Programs and Systems, Inc.
- Decided: Sep 30, 2011 after 70 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K913770 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

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

## Indications for use
ImageLink TM is an integrated medical imaging solutionthat allows for the storage, manipulation, and annotation of high resolution digital radiological images from multiple source modalities. It enhances the efficiency of diagnostic decision making and includes a feature-rich viewer with customizable worklists and hanging protocols that can be organized to meet the unique requirements and style of the individual radiologist.

Source page: https://510kreport.com/device/K112096
Methodology: https://510kreport.com/methodology