# K020661: Unity IS Patient Viewer

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems Information Techn
- Decided: May 24, 2002 after 84 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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 K833395 (1984). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001268: GE Marquette Prism Information Server Applications, General Electric Medical Systems Information Techn (2000) Summary page 1.
- K993008: Quantitative Sentinel System, Marquette Medical Systems, Inc. (1999) Summary page 1.

## Most influential descendants
- K032346: Unity Network IS Patient Viewer (2003), 0 descendants of its own

## Indications for use
The Unity® IS Patient Viewer is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the Unity® IS Patient Viewer is to provide a remote view of physiological parameter data on adult, pediatric and neonatal patients within a hospital or facility providing patient care. The Unity® IS Patient Viewer is NOT intended for primary monitoring but is to be used in conjunction with the bedside monitor. The Unity® IS Patient Viewer is intended to provide near-real-time physiological data and graphical trends for all monitors connected to the Unity Network to secure nurse and physician personal computers (local and remote).

Source page: https://510kreport.com/device/K020661
Methodology: https://510kreport.com/methodology