# K964784: Synergy Cardiology Information System (00431)

- Pathway: 510(k) (Traditional)
- Applicant: Quinton, Inc.
- Decided: Aug 13, 1997 after 259 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945626 (1995). 1 ancestor in all.
29 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945626: Quinton Model 710 Stress Electrocardiograph, Quinton, Inc. (1995) Summary page 1.

## Most influential descendants
- K032038: Pyramis Ecg Management System Model Numbers, 92600 and 92601 (2003), 20 descendants of its own
- K050858: Ascentia Heartstation Ecg Management System (2005), 13 descendants of its own
- K061905: Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0 (2006), 8 descendants of its own
- K113515: Horizon Cardiology Ecg Management (2012), 7 descendants of its own
- K982384: Mercator (1999), 7 descendants of its own

## Indications for use
The intended use of the Quinton Synergy Cardiolagy Information System (CIS) is the acquisition, storage, and display of electrical signals of biological origin, as ECG data, that are obtained from other devices connected directly to the patient. This display on the CIS would only occur at the cessation of data acquisition by the patient connected equipment. (Hence, the CIS would only operate as non-real time system.) Additionally, the CIS may acquire, store, and display administrative data, as patient demographic information. Acquired information may be reviewed, edited, abridged, or re-formatted and distributed electronically or printed.

Source page: https://510kreport.com/device/K964784
Methodology: https://510kreport.com/methodology