Epiphany Cardio Server 6.0
by Epiphany Healthcare Data Management, LLC
Epiphany Cardio Server 6.0 is a Class II device made by Epiphany Healthcare Data Management, LLC, cleared under FDA 510(k) K052883 on 1 Nov 2005 and listed in FDA GUDID since 22 Dec 2020 (UDI-DI 00860991000348), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00860991000348 | Date22 Dec 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK052883 | Date1 Nov 2005 | StatusActive |
Official records
- AccessGUDID record 00860991000348
- FDA 510(k) database K052883
Across registries
- FDA 510(k) K052883 decided 1 Nov 2005 Active
- FDA GUDID UDI-DI 00860991000348 listed 22 Dec 2020 Listed
Recalls
-
- Ongoing Z-2647-2023
Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System software listed below due to a report of the caliper tool becoming non-responsive, preventing the caliper function from being used temporarily on software versions v6.1.x, v6.2.x, and v7.0.x of the E3 user interface.
Timeline
- Cleared FDA 510(k) K052883
- Listed FDA GUDID 00860991000348
- Recall initiated FDA recalls Z-2647-2023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Epiphany Cardio Server
- Generic name
- Cardiology information system application software
- Model / reference
- 6.0
- Primary DI / UDI-DI
- 00860991000348
- 510(k) Number
- FDA product code
- DQK
- GMDN term
- Cardiology information system application software
- Device class
- Class II
- Regulation number
- 870.1425
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code DQK (Computer, Diagnostic, Programmable).
- FusedCO Algorithm by Edwards Lifesciences LLC
- Zio XT ECG Monitoring System, Zio AT ECG Monitoring System by IRHYTHM TECHNOLOGIES, INC.
- MUSE CARDIOLOGY INFORMATION SYSTEM by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II) by Mediguide, Ltd.
- Cardiologs Platform 2.1.xx by CARDIOLOGS TECHNOLOGIES
- MARS HOLTER ANALYSIS WORKSTATION by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- EP-WORKMATE SYSTEM, VERSION 4.2 by ST. JUDE MEDICAL, INC.
- MODIFICATION TO CARTO EP NAVIGATION SYSTEM by Biosense Webster Inc
- EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM by Mennen Medical, Inc.
- ENSITE VELOCITY SYSTEM V.3.0 by ST. JUDE MEDICAL, INC.
Other devices from Epiphany Healthcare Data Management, LLC
See all devices from Epiphany Healthcare Data Management, LLC →