FDA.reportPublic FDA data

Premier Heart MCG Analysis API

Primary DI
B320MCGS0
Brand
Premier Heart MCG Analysis API
Company
PREMIER HEART, LLC
Model
MCGS
Device description
MCG Analysis API (Dedicated Server or Software-as-a-Service)
Published
2024-05-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B320MCGS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac electrophysiology processing softwareA software program designed to add specific image processing and/or data analysis capabilities to a computer for the interpretation and/or screening of cardiac electrophysiology parameters [e.g., electrocardiogram (ECG)]. It is intended for use exclusively by healthcare professionals and may provide risk assessment for cardiac events [e.g., acute myocardial infarction (AMI), acute myocardial ischemic injury (AMII)] or screen for specific conditions (e.g., low ejection fraction). It might include artificial intelligence (AI) and machine learning (ML) technology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
109797584
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B320CF190Premier Heart MCGCF19CF192016-09-27
B320MCGC0Premier Heart MCG Analysis SoftwareMCGC2018-05-17
B320LCA00Premier Heart Reusable Limb Clip ElectrodesLCA02024-05-06
B320LCA10Premier Heart Reusable Limb Clip ElectrodesLCA12024-05-06
B320LCA20Premier Heart Reusable Limb Clip ElectrodesLCA22024-05-06
B320VH120Premier Heart MCG Model VH12VH122018-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
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
00199874185187Vektor Medical vMap SoftwareVektor Medical, Inc.DQK2026-05-08
00195278620873MACGe Medical Systems Information Technologies, Inc.DQK2026-03-31
00195278507037Mac-LabGe Medical Systems Information Technologies, Inc.DQK2026-03-26
00198953107263MACGe Medical Systems Information Technologies, Inc.DQK2026-01-27
00191506052454MDU5 Plus™BOSTON SCIENTIFIC CORPORATIONDQK2025-12-09
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
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
00191506033002AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
00191506033125AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
00191506033194AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
00191506033200AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
17540262170016Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2023-09-19
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyDQK2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyDQK2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyDQK2023-04-19