# K052883: Cardioserver

- Pathway: 510(k) (Traditional)
- Applicant: Datrix
- Decided: Nov 1, 2005 after 19 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945626 (1995). 3 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032038: Pyramis Ecg Management System Model Numbers, 92600 and 92601, Quinton, Inc. (2003) Summary page 1.

## Most influential descendants
- K103427: Mobileecg System (2011), 1 descendant of its own
- K180432: AI-ECG Platform (2018), 0 descendants of its own
- K142349: TM eCloud ECG Analysis System (2015), 0 descendants of its own
- K123466: Healthview Ecg Manager (2012), 0 descendants of its own

## Recalls of this device
- Aug 10, 2023 · Class II · Z-2647-2023: Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System software listed below due to a report of the caliper tool becom

## Indications for use
The CardioServer ECG Management System software is intended to be marketed to medical professionals and for point-of-care use. The software is designed to provide a database used through out the medical community to store, display, edit and print high resolution ECG data received from devices such as electrocardiographs. The CardioServer ECG Management System software allows medical professionals responsible for the diagnosis and treatment of patients (adult and pediatric) with heart disease to: review and edit specific patient ECG data including intervals such as QT measurements and algorithm generated preliminary interpretative statements. ECG records are all associated by patient ID and other demographic data. Secure access to the database is provided.

Source page: https://510kreport.com/device/K052883
Methodology: https://510kreport.com/methodology