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510(k) Data Aggregation
K Number
K191125Device Name
ADAS 3D
Manufacturer
Date Cleared
2020-01-15
(261 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Galgo Medical S.L
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the heart for use on individual patients with cardiovascular disease.
ADAS 3D is indicated for patients with myocardial scar produced by ischemic heart disease. ADAS 3D processes MR and CT images. The quality and the resolution of the medical images determines the accuracy of the data produced by ADAS 3D.
ADAS 3D is indicated to be used only by qualified medical professionals for the visualization and analysis of cardiac images. The data produced by ADAS 3D must not be used as an irrefutable basis or a source of medical advice for clinical diagnosis or patient treatment. The data produced by ADAS 3D is intended to be used to support qualified medical professionals for clinical decision making.
ADAS 3D is not intended to identify regions for catheter ablation or treatment of arrhythmias.
Device Description
ADAS 3D is a software-based image processing tool for post-processing cardiovascular enhanced Magnetic Resonance (MRI) images and Computed Tomography Angiography (CTA) images.
ADAS 3D is designed to process DICOM image databases to enable the calculation, quantification and visualization of 3D cardiac imaging data by displaying and quantifying the levels of enhancement. ADAS 3D also enables the visualization of the cardiac chamber and the adjacent anatomy. After data processing, the data and images can be exported utilizing industry standard formats for viewing on other system, including Electrophysiology (EP) navigation system.
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