FDA.reportPublic FDA data

Change Healthcare Cardiology ECG Management

Primary DI
17540262110166
Brand
Change Healthcare Cardiology ECG Management
Company
Change Healthcare Canada Company
Model
15.1.4
Published
2026-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
17540262110166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1754026211016617540262110166

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).

Regulatory Flags#

DUNS number
246576391
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17540262200102Change Healthcare Stratus Imaging Diagnostic Viewer2.102026-07-22
17540262200096Change Healthcare Stratus Imaging Diagnostic Viewer2.92026-05-27
17540262020014McKesson Radiology12.32018-02-20
17540262140262Change Healthcare Stratus Imaging Viewer1.0.252026-04-16
17540262200010Stratus Imaging Diagnostic Viewer2.12025-10-27
17540262200034Change Healthcare Stratus Imaging Diagnostic Viewer2.32025-10-27
17540262140255Change Healthcare Stratus Imaging Viewer1.0.242026-03-19
17540262140248Change Healthcare Stratus Imaging Viewer1.0.232026-01-29
17540262140231Change Healthcare Stratus Imaging Viewer1.0.222025-11-20
17540262160185Change Healthcare Stratus Imaging PACS1.7.02025-09-15
17540262160161Change Healthcare Stratus Imaging PACS1.4.72024-12-10
17540262130225Change Healthcare Stratus Imaging Viewer1.0.212025-08-05
17540262010060Change Healthcare Enterprise Viewer14.2.12025-06-26
17540262130218Change Healthcare Stratus Imaging Viewer1.0.202025-06-23
17540262030068Change Healthcare Radiology Solutions14.2.22025-05-16
17540262180053Change Healthcare Mammography Plus14.2.22025-05-16
17540262130201Change Healthcare Stratus Imaging Viewer1.0.192025-04-03
17540262160178Change Healthcare Stratus Imaging PACS1.4.82025-04-03
17540262130195Change Healthcare Stratus Imaging Viewer1.0.182024-08-21
17540262160147Change Healthcare Stratus Imaging PACS1.4.62024-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953213063ComboLabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953213087CardioLabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953213094Mac-LabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953243626MLCL Client SoftwareGe Medical Systems Information Technologies, Inc.DQK2026-08-26
05415067055651EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055668EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055675EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055682EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
00885403532040FloTracBecton, Dickinson And CompanyDQK2026-07-31
09349714010877MICROPACE PTY LIMITEDMICROPACE PTY LIMITEDDQK2026-07-21
17540262100150Change Healthcare Cardiology HemoChange 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
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQK2026-02-24
00195278343383CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DQK2026-02-11
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DQK2026-02-11
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
00195278364661CardioSoftGE Medical Systems Information Technologies, Inc.DQK2025-03-25
00843152103027IOPS®Centerline Biomedical, Inc.DQK2025-03-18