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510(k) Data Aggregation
K Number
K113086Device Name
ACQA
Manufacturer
Date Cleared
2012-01-13
(87 days)
Product Code
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
TEXAS MEDICAL IMAGING CONSULTANTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ACQA system is a software on GE Advantage Windows workstation computers that allow the user to create averaged CT images for attenuation correction of the whole body or myocardial perfusion PET images, and to register CT images with myocardial perfusion PET images, and save registered CT images for attenuation correction of myocardial perfusion PET images. The PET images corrected with the CT images of ACQA are not a replacement of the original PET images, and they serve as a secondary data set to assist the physicians read the original PET images.
Device Description
ACQA is a software application installed on GE Advantage Windows workstation computers which allows physicians and healthcare professionals (1) to create averaged CT images for attenuation correction of the whole body oncology or myocardial perfusion PET images, and (2) to register the averaged or helical CT images with their corresponding myocardial perfusion PET images, and save the registered CT images for attenuation correction of the myocardial perfusion PET images. 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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