# K113515: Horizon Cardiology Ecg Management

- Pathway: 510(k) (Traditional)
- Applicant: Mckesson Israel, Ltd.
- Decided: Mar 16, 2012 after 109 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K842308 (1984). 16 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061905: Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0, Medcon, Ltd. (2006) Summary page 1.

## Cited in the summary but kept off the family tree
- K101322: Joinsoon Electronics MFG CO., LTD Infrared Ear Thermometer, Model TT-001, Joinsoon Electronics Mfg Co, Ltd. (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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
- K200822: Braid (2020), 1 descendant of its own
- K252199: AGFA HealthCare Enterprise Imaging (2025), 0 descendants of its own

## Recalls of this device
- Feb 10, 2020 · Class II · Z-1682-2020: Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format
- Dec 19, 2014 · Class II · Z-0910-2015: An ECG procedure time stamp is incorrect, due to a software error in the McKesson Cardiology ECG Management with software versions 13.1 and 13.1.1.

## Indications for use
Horizon Cardiology Tm ECG Management is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices. Horizon Cardiology Tm EGG Management allows analysis or reanalysis of resting EGGs and provides preliminary data for editing and confirmation by an over-reading physician. Horizon Cardiology EGG Management can also provide a serial comparison of resting EGG data to facilitate review of a patient's current ECG with previous EGGs of the same patient. Horizon GardiologyTm ECG Management is intended to be used under the direct supervision of a licensed healthcare practitioner and by trained operators in a hospital or facility providing patient care. Horizon Cardiology EGG Management is not intended for real-time monitoring.

Source page: https://510kreport.com/device/K113515
Methodology: https://510kreport.com/methodology