# K062490: Visage Pacs/CS, Release Version 4.1

- Pathway: 510(k) (Traditional)
- Applicant: Mercury Computer Systems, Inc.
- Decided: Oct 27, 2006 after 63 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: 4 generations back to K945188 (1995). 5 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012086: Aquariusnet Server, Terarecon,Inc. (2001) Summary page 6.

## Most influential descendants
- K080334: Instarad (2008), 2 descendants of its own
- K100236: Stair Systems Pacs & Dicom Viewer (2010), 1 descendant of its own
- K092134: Stat Pacs Picture Archiving & Communication System (Pacs) (2009), 1 descendant of its own
- K171130: Nucleus Image Management System (2017), 0 descendants of its own
- K133357: Charruapacs System (2013), 0 descendants of its own

## Indications for use
Visage PACS/CS: is a system for distributing, viewing, and processing medical images and reports within and outside health care environments. It is to be used only by trained and instructed health care professionals. Visage PACS consists of the following components: Visage PACS Storage: Visage PACS Storage offers an archiving option for long-term storage of image data Visage PACS Web: Data that are stored on the Visage PACS Storage server can be accessed simultaneously by multiple web-based viewing stations within or outside a healthcare enterprise through web clients. Visage CS: Visage CS is a client server system that uses thin client technology for distribution of 3D image data generated from image data of state-of-the-art scanning modalities Integration with other hospital information systems (HIS, RIS, CIS) is provided via special interfaces.

Source page: https://510kreport.com/device/K062490
Methodology: https://510kreport.com/methodology