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510(k) Data Aggregation
K Number
K160334Device Name
Advanced Medical Imaging Software Suite (KSWVWR)
Manufacturer
KEOSYS SAS
Date Cleared
2016-06-21
(134 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
KEOSYS SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Keosys Medical Imaging Suite (KSWVWR) is intended to be used by trained medical professionals included, but not limited to, radiologists, nuclear medicine physicians and physicists.
Keosys Medical Imaging Suite is a software application intended to aid in diagnostic and evaluation of medical image data. Although this device allows the visualization of mammography images, it is not intended as a tool for primary diagnosis in mammography.
Keosys Medical Imaging Suite can be used for display, process, temporarily store, print and also create and print reports from 2D and 3D multimodal DICOM medical image data. The imaging data can be Computed Tomography (CT), Magnetic Resonance (MR), Radiography X (CR, DX, XRF, MG), Nuclear Medecine (NM) including planar imaging (Static, Whole body, Dynamic, Gated) and tomographic imaging (SPECT, Gated SPECT), Positon Emission Tomography (PT), Ultrasound (US).
Keosys Medical Imaging suite provides tools like rulers, markers or region of interests (e.g. it can be used in an oncology clinical workflow for tumor burden assessment or therapeutic response evaluation).
It is the user responsibility to check that the ambient luminosity conditions, the images compression ratio and the interpretation monitor specifications are consistent with a clinical diagnostic use of the data.
Device Description
Keosys' Advanced Medical Imaging Software Suite (aka Viewer, aka KSWVWR) is a multimodality diagnostic workstation for visualization and 3D post-processing of Radiological and Nuclear Medicine medical images. It includes dedicated applications for the therapeutic response evaluation process in a multi-vendor, multi-modal and multi time-points context. The solution also includes the latest recommendations for SUV calculation.
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