FDA.reportPublic FDA data

Change Healthcare Cardiology

Primary DI
17540262090154
Brand
Change Healthcare Cardiology
Company
Change Healthcare Canada Company
Model
15.1.2
Published
2026-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212528000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212528000Change Healthcare CardiologyChange Healthcare Israel , Ltd.2021-10-18LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17540262090154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1754026209015417540262090154

GMDN Terms#

Term, Definition table
TermDefinition
Cardiology information systemA dedicated assembly of devices designed 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. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).

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
17540262200096Change Healthcare Stratus Imaging Diagnostic Viewer2.92026-05-27
17540262140262Change Healthcare Stratus Imaging Viewer1.0.252026-04-16
17540262140248Change Healthcare Stratus Imaging Viewer1.0.232026-01-29
17540262140255Change Healthcare Stratus Imaging Viewer1.0.242026-03-19
17540262140231Change Healthcare Stratus Imaging Viewer1.0.222025-11-20
17540262100143Change Healthcare Cardiology Hemo15.1.22026-03-09
17540262110142Change Healthcare Cardiology ECG Management15.1.22026-03-09
17540262170047Change Healthcare Cardiology Hemodynamics15.1.22026-03-09
17540262130225Change Healthcare Stratus Imaging Viewer1.0.212025-08-05
17540262130218Change Healthcare Stratus Imaging Viewer1.0.202025-06-23
17540262200010Stratus Imaging Diagnostic Viewer2.12025-10-27
17540262200034Change Healthcare Stratus Imaging Diagnostic Viewer2.32025-10-27
17540262160185Change Healthcare Stratus Imaging PACS1.7.02025-09-15
17540262160161Change Healthcare Stratus Imaging PACS1.4.72024-12-10
17540262130201Change Healthcare Stratus Imaging Viewer1.0.192025-04-03
17540262130195Change Healthcare Stratus Imaging Viewer1.0.182024-08-21
17540262010060Change Healthcare Enterprise Viewer14.2.12025-06-26
17540262030068Change Healthcare Radiology Solutions14.2.22025-05-16
17540262180053Change Healthcare Mammography Plus14.2.22025-05-16
17540262160178Change Healthcare Stratus Imaging PACS1.4.82025-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M722CD26127V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-05-28
17540262200096Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-05-27
75401622522101Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-05-27
08437021722093ADAS 3DADAS3D MEDICAL S.L.LLZ2026-05-12
08800133400003ZeTTA PACSTae Young Soft Co., Ltd.LLZ2026-05-12
08033837938835no brandCEFLA SOCIETA' COOPERATIVALLZ2026-05-11
G725QFR300QFRQFR Solutions B.V.LLZ2026-05-11
G725QFR310QFRQFR Solutions B.V.LLZ2026-05-11
08800130800080Laon OrthoLaon Medi Inc.LLZ2026-05-07
G713ELU0010ElucisRealize Medical Inc.LLZ2026-05-07
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
M722C26103V260970ClearRead CT ServerRiverain Technologies, Inc.LLZ2026-04-20
M722CC26103V260970ClearRead CT ConsoleRiverain Technologies, Inc.LLZ2026-04-20
M722CD26103V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-04-20
M722CP26104V261040ClearRead CT Platform DockerRiverain Technologies, Inc.LLZ2026-04-20
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13
08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800066200619JLK-AILINKJLK, Inc.LLZ2026-03-25
08800066200787JLK-CTPJLK, Inc.LLZ2026-03-25
08800066200794JLK-PWIJLK, Inc.LLZ2026-03-25
08800130400303Neurophet AQUA AD PlusNEUROPHET Inc.LLZ2026-02-24
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.LLZ2026-01-28