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510(k) Data Aggregation
K Number
K172858Device Name
PreOp
Manufacturer
Epilog
Date Cleared
2018-01-08
(110 days)
Product Code
OLX
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
Epilog
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PreOp is intended for use by a trained/qualified EEG technologist or physician on both adult and pediativ subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.
Device Description
PreOp is medical device software that combines EEG data and MR images to visualize recorded EEG activity in 3D in the brain. PreOp can be subdivided in 3 main modules: 3D Electrical Source Imaging (i.e. 3D ESI), Report generation and Viewer generation. The device's input is the MRI and EEG data that are uploaded by the user to the PreOp cloud environment. The output of the device is a report containing the results of the visualization and the ability to evaluate the results in 3D using the 3D viewer. The user can access the output through the PreOp cloud environment.
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