FDA.reportPublic FDA data

McKesson Cardiology

Primary DI
80010939070025
Brand
McKesson Cardiology
Company
Change Healthcare Canada Company
Model
14.0
Published
2017-03-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K112720000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112720000MCKESSON HORIZON CARDIOLOGYMckesson Israel , Ltd.2012-01-30LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
80010939070025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8001093907002580010939070025

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
17540262090154Change Healthcare Cardiology15.1.22026-03-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628184004500Intellijoint VIEWIntellijoint Surgical IncLLZ2026-06-09
00860005144082Brain AgeDeephealth, Inc.LLZ2026-06-08
07649997938038Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
07649997938052Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-06-05
00850631008865Roentgen WorksBrit Systems, LLCLLZ2026-06-05
08437021468212QP-ProstateQUIBIM SOCIEDAD LIMITADA.LLZ2026-06-05
B359OAIIV2026051RamsoftRamsoft IncLLZ2026-06-04
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
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