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510(k) Data Aggregation
K Number
K181720Device Name
Epiphany Cardio Server Mobile
Manufacturer
Date Cleared
2018-07-30
(31 days)
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
Epiphany Healthcare, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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.
Device Description
The Epiphany Cardio Server Mobile provides secure access to ECG records and related information contained on the Cardio Server ECG Management System. The Epiphany Cardio Server Mobile software functions as an accessory to the Cardio Server ECG Management System, and requires a WIFI or cellular connection to a pre-installed and properly configured Cardio Server ECG Management System. Through providing remote access to the ECG data stored on the Cardio Server ECG Management System, the user is able to review current and previous ECG tests, results, and perform measurements on the ECG waveforms. Cardio Server Mobile does not store ECG or patient related information on the mobile device, does not directly communicate with cardiographs or other waveform acquisition devices, and does not use any automatic electronic data processing and pattern recognition methods to derive measurements (e.g. intervals and amplitudes) or provide diagnostic statements from the ECG data. The device does not allow modification of the original ECG traces (waveforms) stored on the Cardio Server ECG Management System.
The Epiphany Cardio Server Mobile application is not intended to replace the functionalities provided by the Cardio Server ECG Management System desktop client but to extend those to make selected functionalities described above available via mobile devices.
The Epiphany Cardio Server Mobile functions as a non-real time system and is not intended for real time monitoring.
The Epiphany Cardio Server Mobile can be used both inside and outside of medical facilities except in areas where cellular phone or wireless device use is prohibited.
The Epiphany Cardio Server Mobile is intended to operate on Apple iPad and iPhone running iOS mobile operating system from Apple Inc.
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