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510(k) Data Aggregation
K Number
K080770Device Name
IMAGENMD WITH IMAGENQ
Manufacturer
CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC
Date Cleared
2008-04-09
(22 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ImagenMD™ with ImagenQ™ system is software that allows the user to visualize raw PET and/or PET/CT data, assist in evaluating the quality of PET scans, and perform quantitative measurements of tracer uptake to aid in the interpretation of myocardial perfusion PET images.
Device Description
ImagenMD™ with ImagenQ™ is a Windows software application which allows physicians and healthcare professionals to inspect, quantitatively and automatically perform calculations on myocardial perfusion PET images. The user can perform quality assessments, automatically and manually select myocardial boundaries and alignment, and visualize the results of quantitative perfusion calculations. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.
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K Number
K050366Device Name
IMAGENPRO
Manufacturer
CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC
Date Cleared
2005-03-17
(31 days)
Product Code
KPS
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ImagenPRO™ system is a software and/or computer system that allows the user to visualize raw PET and/or PET/CT data, reconstruct myocardial perfusion PET or PET/CT images and reorient PET and/or PET/CT reconstructed tomograms.
Device Description
ImagenPRO™ is a software application installed on desktop computers which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion PET images. The system processes perfusion and gated PET raw emission and transmission data to create 3D tomographic data. The user can select correction parameters, filter setting, range of reconstruction, and reorientation angles. Use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.
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K Number
K041671Device Name
IMAGENMD
Manufacturer
CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC
Date Cleared
2004-07-22
(31 days)
Product Code
KPS
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ImagenMD™ system is a software and computer system that allows the user to view myocardial perfusion SPEC or PET images from a remote location. The system allows the user to view quantify and process perfusion and gated SPECT images.
Device Description
ImagenMD™ is a software application installed on laptop computers which allows physicians and healthcare professionals to view myocardial perfusion SPECT or PET images from their office, hospital or home. The system processes perfusion and gated SPECT performing quantitative data analysis. The user can select raw, short axis, transmission slice and gated short axis studies for the purpose of examining those images for abnormalities and artifacts. The system contains optional databases which quantify the extent and severity of myocardial defects. Also included is an application for the display and analysis of gated short axis blood pool SPECT datasets. Use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.
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