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3 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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Imeka Solutions, Inc.
Authorized purpose: ANDI 2.2 processes brain MR images for atlas-assisted visualization, segmentation and volumetric quantification, presenting adjunctive DICOM-readable information for trained medical professionals; it does not predict, diagnose or interpret brain health.
Imeka Solutions, Inc.
Authorized purpose: Adjunctive quantitative brain MRI analysis that compares patient measures with normative and longitudinal references; a physician reviews all results and makes the clinical decision.
Imeka Solutions, Inc.
Authorized purpose: ANDI processes diffusion-weighted MRI with auxiliary T1 imaging to create 3D white-matter tract maps and microstructure reports for trained medical professionals as adjunctive measurement information, not diagnosis.