# K032038: Pyramis Ecg Management System Model Numbers, 92600 and 92601

- Pathway: 510(k) (Abbreviated)
- Applicant: Quinton, Inc.
- Decided: Sep 5, 2003 after 66 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945626 (1995). 2 ancestors in all.
20 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964784: Synergy Cardiology Information System (00431), Quinton, Inc. (1997) Summary page 1.

## Most influential descendants
- 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
- K133534: Mckesson Cardiology Ecg Mobile (2014), 6 descendants of its own
- K151774: CARESTREAM Vue Motion (2015), 4 descendants of its own

## Indications for use
The system may be used to store, retrieve, edit and report records of biologic origin such as ECG, exercise stress and Holter tests. The system can receive tests from a variety of devices. Data is then available through onscreen display, printer, email, fax, HIS (Hospital Information System) results reporting interface or via customized database queries. Users may view and edit interpretative statements and measurements through the onscreen display. The system can calculate multiple QTc metrics based upon acquired ECG data. The system does not modify the original ECG waveform information, nor does it provide an automated ECG interpretive analysis of the data. The system is designed to provide information for qualified clinicians responsible for the diagnosis and treatment of patients (adult and pediatric) with heart disease. The system is designed for use in a clinical setting by physicians, nurses, clinical technicians, medical records personnel and medical record transcriptionists.

Source page: https://510kreport.com/device/K032038
Methodology: https://510kreport.com/methodology