IB NEURO, VERSION 1.0
IMAGING BIOMETRICS, LLCIB Neuro v1.0 is software that processes MRI data to create maps showing blood flow and volume in the brain. These maps help doctors evaluate brain perfusion and may assist in clinical decision-making. The software integrates easily with existing MRI systems and PACS to streamline the workflow for clinicians.
Intended Use
IB Neuro software allows the processing and display of dynamically acquired MR datasets to evaluate image intensity variations over time, generating perfusion maps such as relative cerebral blood volume, cerebral blood flow, mean transit time, and time to peak, and sends these maps to a PACS for viewing.
Technology
Software plugin for OsiriX platform designed to analyze dynamically acquired MRI datasets using established algorithms to produce parametric perfusion maps (rCBV, CBF, MTT, TTP). It features automated contrast leakage correction, brain mask generation, parameter normalization to normal white matter, interactive arterial input function selection, and automated report generation, and integrates with PACS via DICOM.
Performance
Performance testing included software validation, verification and testing per FDA software validation guidance. No clinical tests were performed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/18/2008
1 month - 2
FDA Approval
5/15/2008
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