# K050858: Ascentia Heartstation Ecg Management System

- Pathway: 510(k) (Abbreviated)
- Applicant: Heartlab, Inc.
- Decided: Jun 29, 2005 after 85 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- 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: 4 generations back to K842308 (1984). 14 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031970: Infinity Megacare, Siemens Medical Solutions USA, Inc. (2003) Summary page 3.
- K946281: Eclipse 4 Electrocardiograph, Burdick, Inc. (1996) Summary page 3.
- K032103: Philips Tracemaster Ecg Management System, Models M5100A and M5101A, Philips Medical Systems (2003) Summary page 3.
- K032038: Pyramis Ecg Management System Model Numbers, 92600 and 92601, Quinton, Inc. (2003) Summary page 3.

## Most influential descendants
- 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
- K170434: Enterprise Imaging XERO Viewer 8.1 (2017), 3 descendants of its own

## Recalls of this device
- May 7, 2009 · Not classified · Z-0366-2010: HeartStation does not refresh content changes to the PDF reports that are printed emailed or faxed from the Index page. This may lead to a discrepancy in patient demographics between what is displayed

## Indications for use
The Heartlab HeartStation T 'M ECG Management System is a comprehensive data management solution which automates the processing, storage and display ofT electrocardiograms (ECGs) throughout a healthcare enterprise. HeartStation M accepts standard 12-lead ECGs, which originate from any one of a variety of manufacturers' cardiographs and patient monitors, and normalizes them to a common format. ECGs are then measured, interpreted, compared to previous ECGs ( 4serial comparison"), optionally printed and stored with a preliminary diagnosis. A graphical user interface allows a physician to review these computer-generated reports, modify them or add comments as appropriate, electronically apply his or her signature and trigger the automatic distribution of final, confirmed diagnostic reports to other care providers.

Source page: https://510kreport.com/device/K050858
Methodology: https://510kreport.com/methodology