# K073372: Electrophysiology Systems Integrator (Epsi)

- Pathway: 510(k) (Traditional)
- Applicant: Systemsone
- Decided: Dec 7, 2007 after 4 days
- Product code: DXJ (Display, Cathode-Ray Tube, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2450
- 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 K941811 (1994). 21 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053356: Modification to: Cic Pro Clinical Information Center Central Station, Ge Medical Systems Information Technologies (2006) Summary page 1.
- K992636: HP Carevue 9000 Clinical Information System, Model M2331A, Hewlett-Packard Co. (1999) Summary page 1.
- K962811: Spacelabs Medical Multi-Disclosure Workstation, Spacelabs Medical, Inc. (1997) Summary page 1.

## Most influential descendants
- K083321: Cardio-View (2008), 9 descendants of its own
- K111320: Globalcardio (2011), 3 descendants of its own
- K122632: Guava II (2014), 2 descendants of its own
- K112645: Radiforce Large Monitor System (2011), 2 descendants of its own
- K172969: Essence 55S Large Monitor System (2018), 1 descendant of its own

## Indications for use
The EPSI system is intended to be used by health care professionals to integrate the video outputs from several commercially-available instruments into a single video display. These instruments may be commonly found in the electrophysiology laboratory, cardiac catheterization laboratory or where special or general fluoroscopy is used. Control of the video sources is accomplished using a touchpad device.

Source page: https://510kreport.com/device/K073372
Methodology: https://510kreport.com/methodology