# K082269: Visage Pacs, Version 6.0/CS 3.1

- Pathway: 510(k) (Traditional)
- Applicant: Visage Imaging, Inc.
- Decided: Dec 12, 2008 after 123 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 K945188 (1995). 7 ancestors in all.
20 later devices descend from it; 6 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072205: Visage Pacs/CS, Release Version 5.0, Mercury Computer Systems, Inc. (2007) Summary page 1.
- K011142: Aquarius Workstation, Terarecon,Inc. (2001) Summary page 2.

## Most influential descendants
- K111319: Ibis Explorer and Markup Software (2011), 6 descendants of its own
- K203249: Nucleus.io (2020), 5 descendants of its own
- K122205: EXINI (2012), 5 descendants of its own
- K222476: OmegaAI Image Viewer (2022), 3 descendants of its own
- K191262: aBSI (2019), 2 descendants of its own

## Indications for use
Visage PACS/IS is a system for distributing, viewing, processing, and archiving medical images within and outside health care environments. The Visage PACS/CS server receives image data in DICOM format via the hospital network. This provides universal connections to archives, modalities, and workstations. The supported modalities are listed in the DICOM Conformance Statement. Besides general image interpretation and processing tools, Visage PACS/CS provides specific tool sets for several clinical applications, including: - CT/MR angiography, e.g. for vascular analysis and stent planning - Cardiac analysis, including calcium scoring and functional assessment of cardiac CT data Neuroradiology, including CT and MR brain perfusion analysis Oncology, including SUV analysis and lesion marking and analysis Visage PACS/CS is to be used only by trained and instructed health care professionals. It can support physicians and/or their medical staff in providing their own diagnosis for medical cases. The final decision regarding diagnoses, however, resides with the doctors and/or their medical staff in their own area of responsibility. Although -the web fiad-hfiie- - n ftechfoniesi ajiow- the ,sob-ii/' to- be rUnin6io a variety of hardware platforms, for diagnostic purposes the user must make sure that the display hardware used for reading the images complies with state-of-the-art diagnostic requirements and currently valid laws. 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/K082269
Methodology: https://510kreport.com/methodology