# K023476: Unipacs Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Universal Pacs, Inc.
- Decided: Jan 7, 2003 after 83 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 K896095 (1990). 5 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012211: Efilm Workstation, Efilm Medical, Inc. (2001) Summary page 1.

## Most influential descendants
- K081304: Alz Web Pacs, Version 1.0 (2008), 8 descendants of its own
- K130624: CONI (2013), 7 descendants of its own
- K153653: DICOM Viewer (2016), 4 descendants of its own
- K191014: Elements Viewer (2020), 3 descendants of its own
- K071894: Xebra Dicom Image Browser (2007), 2 descendants of its own

## Indications for use
UniPACS Workstation software is intended to be used as a fully-functional, PC-based PACS software application, to review, interpret, manipulate, network, print and visualize medical multi-modality image data in DICOM format. When interpreted by a trained physician, reviewed images can be used as an element for diagnosis. Typical users of this system are trained professionals, including but not limited to physicians, nurses and technicians.

Source page: https://510kreport.com/device/K023476
Methodology: https://510kreport.com/methodology