# K112008: Touchpacs Suite

- Pathway: 510(k) (Traditional)
- Applicant: Touch Medical Solutions, Inc.
- Decided: Jan 6, 2012 after 177 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: 7 generations back to K913770 (1991). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100236: Stair Systems Pacs & Dicom Viewer, Stair Systems, Inc. (2010) 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.
- K051553: Fuji Synapse Workstation Software, Fujifilm Medical Systems U.S.A, Inc. (2005) Summary page 1.

## Indications for use
The TouchPACS 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 TouchPACS Suite 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. TouchPACS; TouchMGR Suite 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 TouchPACS Suite software is not for mammographic use.

Source page: https://510kreport.com/device/K112008
Methodology: https://510kreport.com/methodology