# K100236: Stair Systems Pacs & Dicom Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Stair Systems, Inc.
- Decided: Mar 29, 2010 after 62 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: 6 generations back to K913770 (1991). 41 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062490: Visage Pacs/CS, Release Version 4.1, Mercury Computer Systems, Inc. (2006) Summary page 1.
- K031562: Ramsoft Pacs, Model 3.0, Ramsoft, Inc. (2003) Summary page 1.
- K062878: Ezpacs, Version 3.0, Advanced Imaging Solutions, LLC (2007) Summary page 1.
- K062164: Resolutionmd, Version 1.3, Calgary Scientific, Inc. (2006) Summary page 1.
- K051553: Fuji Synapse Workstation Software, Fujifilm Medical Systems U.S.A, Inc. (2005) Summary page 1.

## Most influential descendants
- K112008: Touchpacs Suite (2012), 0 descendants of its own

## Indications for use
The Stair Systems Constellation Suite Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The STAIR System PACS & DICOM Viewer Software is comprised of modular software programs that run on standard "off-the-shelf' personal computers, business computers, and servers running standard operating systems. STAIR System & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from any OEM modality which support DICOM standard imaging data; The system provides the capability to organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, and perform quantitative measurements. The STAIR Systems Constellation Suite Software system should not be used for Diagnostic review of full-field digital mammograms.

Source page: https://510kreport.com/device/K100236
Methodology: https://510kreport.com/methodology