FDA-cleared K261405

ANDI 2.2

Imeka Solutions, Inc.

ANDI 2.2 processes brain MR images for atlas-assisted visualization, segmentation and volumetric quantification, presenting adjunctive DICOM-readable information for trained...

Modality
MRI
Anatomy
Brain
Decision
2026-05-28
FDA-cleared K252298

ANDI 2.0

Imeka Solutions, Inc.

Adjunctive quantitative brain MRI analysis that compares patient measures with normative and longitudinal references; a physician reviews all results and makes the clinical...

Modality
MRI
Anatomy
Brain
Decision
2025-10-22
FDA-cleared K230913

ANDI

Imeka Solutions, Inc.

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...

Modality
MRI
Anatomy
Brain
Decision
2023-07-25