FDA.reportPublic FDA data

Premier Heart MCG Analysis Software

Primary DI
B320MCGC0
Brand
Premier Heart MCG Analysis Software
Company
PREMIER HEART, LLC
Model
MCGC
Device description
Premier Heart MCG Analysis Cluster software, including: - MCG Clinical Client (reference implementation and API) - MCG Webapps/Report Generator - MCG Clinical Database - MCG Analysis Engine
Published
2018-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
B320MCGC0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac electrophysiology application softwareA software program designed to add specific image processing and/or data analysis capabilities to a computer for the interpretation of cardiac electrophysiology parameters [e.g., electrocardiogram (ECG)]. It may provide risk assessment for cardiac events [e.g., acute myocardial infarction (AMI), acute myocardial ischemic injury (AMII)] and/or include the ability to record images and movies.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
516-883-3383support@premierheart.com

Regulatory Flags#

DUNS number
109797584
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B320MCGS0Premier Heart MCG Analysis APIMCGS2024-05-03
B320CF190Premier Heart MCGCF19CF192016-09-27
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

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Primary DI, Brand, Company table
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