Epiphany Cardio Server Mobile
by Epiphany Healthcare, LLC 510(k)
Active
510(k) K181720
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK181720 | Date30 Jul 2018 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DQK
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1425
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
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. It is intended to be used from a mobile device to view ECG test results, such as waveforms and measurements.
The device is supplied as a software application for mobile use and is regulated under FDA 510(k) clearance K181720. It was determined to be substantially equivalent to a predicate device and reviewed by the Cardiovascular advisory committee. No information regarding sterility, single-use or reusable status, MRI safety, sizes, or storage conditions is provided in the data.
Questions
AI-generated answers, 1 Oct 2026
What is the Epiphany Cardio Server Mobile used for?
It is used to access and display ECG data and related patient information that was previously stored, analyzed, or received by the Cardio Server ECG Management System, allowing clinicians to view ECG waveforms and measurements from a mobile device.
How is the Epiphany Cardio Server Mobile supplied to users?
The device is supplied as a software application designed for mobile use, meaning it is downloaded and installed on compatible mobile devices rather than provided as physical hardware.
Is the Epiphany Cardio Server Mobile a single-use or reusable device?
As a software application, it is not subject to single-use or reusable classifications in the traditional sense; it can be used repeatedly on mobile devices for viewing ECG data without physical degradation or contamination concerns.