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510(k) Data Aggregation
K Number
K082041Device Name
FIATLUX VISUALIZE
Manufacturer
FIATLUX IMAGING INC.
Date Cleared
2008-08-01
(14 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
FIATLUX IMAGING INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FiatLux Visualize™ is a medical diagnosis software application that allows physicians, radiologists, medical technicians, nurses, and other trained medical professionals to select, review and analyze DICOM images acquired from CT and MR devices. It provides a suite of tools for 2D/3D reconstruction based on the input image dataset.
FiatLux Visualize™ software must be installed on a suitable commercial computer platform. It is the user's responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications. Mammographic and compressed images are not supported for viewing.
Device Description
FiatLux Visualize™ is a medical device software application that provides multidimensional visualization of CT and MR medical images. FiatLux Visualize allows the user to select and retrieve a patient series, display and view the images and data, interactively manipulate the images to visualize anatomy and pathology, and analyze the images using a set of tools. It reads DICOM CT and MR images transferred using removable media or Microsoft Windows networking.
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