# K133534: Mckesson Cardiology Ecg Mobile

- Pathway: 510(k) (Traditional)
- Applicant: Mckesson Israel, Ltd.
- Decided: Apr 18, 2014 after 151 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: 7 generations back to K842308 (1984). 18 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113515: Horizon Cardiology Ecg Management, Mckesson Israel, Ltd. (2012) Summary page 1.
- K122133: Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing, Airstrip Technologies, LP (2012) Summary page 1.

## Most influential descendants
- 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
- K231385: Rology Teleradiology Platform (v.1.22.1103) (2023), 0 descendants of its own

## Indications for use
McKesson Cardiology ECG Mobile is a software application used for accessing and displaying ECG data and related patient information previously stored, analyzed or retrieved by the Horizon Cardiology ECG Management device. The McKesson Cardioclogy ECG Mobile software application is intended to be used from a mobile device to perform the following: View ECG test results, such as waveforms, synopsis measurements and diagnosis statements, as well as other relevant current or historical patient information originally stored, analyzed or retrieved by the Horizon Cardiology ECG Management device. View the ECG lead traces using different display settings. Compare the results of current ECG tests with any previous ECG test results stored on the Horizon Cardiology ECG Management device. Perform ECG-related measurements and edit synopsis measurement values stored on the Horizon Cardiology ECG Management device. Enter new diagnosis statements and/or modify diagnosis records stored on the Horizon Cardiology ECG Management device. Confirm ECG procedures and resuits. Communicate information with the Horizon Cardiology ECG Management device such as login credentials and user settings. The McKesson Cardiology ECG Mobile application is intended to be used under the direct supervision of a licensed healthcare practitioner and by trained operators. The McKesson Cardiology ECG Mobile application is not intended for real-time monitoring.

Source page: https://510kreport.com/device/K133534
Methodology: https://510kreport.com/methodology