FDA.reportPublic FDA data

Cardio Server

Primary DI
00860991000386
Brand
Cardio Server
Company
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
Model
7.1
Device description
ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
Published
2023-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052883000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052883000CARDIOSERVERDatrix2005-11-01DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860991000386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860991000386008609910003868609910003860860991000386

GMDN Terms#

Term, Definition table
TermDefinition
Cardiology information system application softwareAn application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of cardiology services and facilities. It is typically supplied for installation into a dedicated information system for cardiology or existing mainframe or decentralized computers/networks.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079747524
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860991000393Cardio Server 7.4.02024-03-12
00860991000379Cardio Server 7.02022-10-31
00860991000362Cardio Server 6.2 2022-02-23
00860991000355 Cardio Server 6.12021-07-19
00860991000348Epiphany Cardio Server 6.02020-12-22
00860991000331Epiphany Cardio Server 5.42020-06-08
00860991000300Epiphany Cardio Server 5.1.02016-09-09
00860991000324Epiphany Cardio Server 5.32018-11-12
00860991000317Epiphany Cardio Server 5.2.02017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838118898IECGPhilips Medizin Systeme Böblingen GmbHDQK2026-06-23
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
00854277008197NorthStar Mapping SystemImricor Medical Systems, Inc.DQK2026-05-21
08719689142124QMAPP Fysicon B.V.DQK2026-05-19
08719689142131QMAPP Fysicon B.V.DQK2026-05-19
08719689142162QMAPP Fysicon B.V.DQK2026-05-19
08719689142179QMAPP Fysicon B.V.DQK2026-05-19
17540279200027CardioSTATIcentia Inc.DQK2025-12-08
08800069700109AT-ReportATsens Co., Ltd.DQK2025-11-05
08800069700246ATACC-C130AATsens Co., Ltd.DQK2025-11-05
08800069700260AT-PatchATsens Co., Ltd.DQK2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DQK2025-11-05
B353UA2251DA1UbiqVueLifesignals, Inc.DQK2025-04-22
B353UA2251SA1UbiqVueLifesignals, Inc.DQK2025-04-22
27540279250029CardioSTATIcentia Inc.DQK2024-12-18
27540279250074CardioSTATIcentia Inc.DQK2024-12-18
27540279250142CardioSTATIcentia Inc.DQK2024-12-18
G637CEA0Cardiologs PlatformPHILIPS FRANCEDQK2024-09-23
17540279105018EARTIcentia Inc.DQK2024-03-26
17540279200072CardioSTATIcentia Inc.DQK2024-03-26
17540279200140CardioSTATIcentia Inc.DQK2024-03-26
17540262170016Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2023-09-19
08800069700178AT-PatchATsens Co., Ltd.DQK2022-12-23
B273CEA0Cardiologs PlatformCARDIOLOGS TECHNOLOGIESDQK2021-12-08
08714729982845MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
08714729982852MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
08714729982876MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
00191506015084AVVIGO™ Guidance System IIBOSTON SCIENTIFIC CORPORATIONDQK2021-11-17
00191506015169AVVIGO™ Guidance System IIBOSTON SCIENTIFIC CORPORATIONDQK2021-11-17
00191506015176AVVIGO™ Guidance System IIBOSTON SCIENTIFIC CORPORATIONDQK2021-11-17