# K181720: Epiphany Cardio Server Mobile

- Pathway: 510(k) (Traditional)
- Applicant: Epiphany Healthcare, LLC
- Decided: Jul 30, 2018 after 31 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: 8 generations back to K842308 (1984). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133534: Mckesson Cardiology Ecg Mobile, Mckesson Israel, Ltd. (2014) Summary page 4.

## Indications for use
Epiphany Cardio Server Mobile is a software application used for accessing and displaying ECG data and related patient information previously stored, analyzed or received by the Cardio Server ECG Management System. The Epiphany Cardio Server Mobile software application is intended to be used from a mobile device to perform the following: • View ECG test results, such as waveforms, measurements and diagnosis statements as well as other relevant current or historical patient information originally stored, analyzed or received by the Cardio Server ECG Management System. • View the ECG lead traces using different display settings. • Compare the results of current ECG tests with the patient’s previous ECG test results stored on the Cardio Server ECG Management System. • Perform manual ECG-related measurements using the electronic caliper tool. • Communicate information with the Cardio Server ECG Management System such as login credentials and user settings. Epiphany Cardio Server Mobile application is intended to be used under the direct supervision of a licensed healthcare practitioner and by trained operators. Epiphany Cardio Server Mobile is not intended for real time monitoring.

Source page: https://510kreport.com/device/K181720
Methodology: https://510kreport.com/methodology