FDA.reportPublic FDA data

Change Healthcare Cardiology ECG Management

Primary DI
17540262110098
Brand
Change Healthcare Cardiology ECG Management
Company
Change Healthcare Canada Company
Model
15.0
Published
2022-02-28
Public version status
Update
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
17540262110098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1754026211009817540262110098

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
246576391
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17540262200126Change Healthcare Stratus Imaging Diagnostic Viewer2.122026-10-05
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

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Primary DI, Brand, Company table
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00198953002186Carescape Dock F0GE Healthcare Finland OyDQK2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDQK2026-10-04
05415067057952EnSite™ST. JUDE MEDICAL, INC.DQK2026-09-21
05415067057969EnSite™ST. JUDE MEDICAL, INC.DQK2026-09-21
00191506063214OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDQK2026-09-20
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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
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00885403532040FloTracBecton, Dickinson And CompanyDQK2026-07-31
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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
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