# K072205: Visage Pacs/CS, Release Version 5.0

- Pathway: 510(k) (Special)
- Applicant: Mercury Computer Systems, Inc.
- Decided: Aug 29, 2007 after 21 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.
36 later devices descend from it; 4 cite it directly.
0 of 42 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 1.

## Most influential descendants
- K082269: Visage Pacs, Version 6.0/CS 3.1 (2008), 20 descendants of its own
- K082430: Syngo Imaging XS (2008), 11 descendants of its own
- K093612: Syngo.Plaza (2010), 10 descendants of its own
- K101666: Syngo. Plaza VA20A (2010), 9 descendants of its own
- K132532: Syngo.Plaza VB10A (2013), 8 descendants of its own

## Indications for use
Visage PACS 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. Only DICOM for presentation images can be used on an FDA approved monitor for mammography for primary image diagnosis. Only uncompressed or non-lossy compressed images must be used for primary image diagnosis in mammography.

Source page: https://510kreport.com/device/K072205
Methodology: https://510kreport.com/methodology