Epiphany Cardio Server 5.3
by Epiphany Healthcare Data Management, LLC
Epiphany Cardio Server 5.3 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 12 Nov 2018 (UDI-DI 00860991000324), 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 | Number00860991000324 | Date12 Nov 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK052883 | Date1 Nov 2005 | StatusActive |
Official records
- AccessGUDID record 00860991000324
- FDA 510(k) database K052883
Across registries
- FDA 510(k) K052883 decided 1 Nov 2005 Active
- FDA GUDID UDI-DI 00860991000324 listed 12 Nov 2018 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 00860991000324
- 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- Withdrawn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
- 5.3
- Primary DI / UDI-DI
- 00860991000324
- 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
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