FDA.reportPublic FDA data

Change Healthcare Cardiology ECG Management

Primary DI
17540262110012
Brand
Change Healthcare Cardiology ECG Management
Company
CHANGE HEALTHCARE ISRAEL LTD
Model
14.1
Published
2018-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
K113515000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113515000HORIZON CARDIOLOGY ECG MANAGEMENTMckesson Israel , Ltd.2012-03-16DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17540262110012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1754026211001217540262110012

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping system computerA dedicated computer with software that is a component of a cardiac mapping system and is used to process and store electronic information/data for the interpretation of cardiac physiological parameters received from the output of connected measuring devices [e.g., body surface or intracardiac electrocardiograph (ECG) sensors/transducers]. The measurements can be compared to pre-established diagnostic criteria for parameters such as cardiac blood flow, electrical conduction, or heart chamber geometry. The device may display real-time cardiac maps in various formats (e.g., electrical propagation maps, electrical potential maps, and cardiac chamber geometry maps).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600748180
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17540262120028Change Healthcare Cardiology ECG Mobile1.32019-04-15
17540262120011Change Healthcare Cardiology ECG Mobile1.2.42018-05-20
17540262090024Change Healthcare Cardiology14.1.12018-11-22
17540262100020Change Healthcare Cardiology Hemo14.1.12018-11-22
17540262110029Change Healthcare Cardiology ECG Management14.1.12018-11-22
17540262090017Change Healthcare Cardiology14.12018-08-20
17540262100013Change Healthcare Cardiology Hemo14.12018-08-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09349714010877MICROPACE PTY LIMITEDMICROPACE PTY LIMITEDDQK2026-07-21
17540262100150Change Healthcare Cardiology HemoChange Healthcare Canada CompanyDQK2026-07-21
17540262110166Change Healthcare Cardiology ECG ManagementChange Healthcare Canada CompanyDQK2026-07-21
17540262170054Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2026-07-21
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
08714729982845MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
08714729982852MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
08714729982876MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29