# K261405: ANDI 2.2

- Pathway: 510(k) (Special)
- Applicant: Imeka Solutions, Inc.
- Decided: May 28, 2026 after 29 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K081512 (2008). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252298: ANDI 2.0, Imeka Solutions, Inc. (2025) Summary page 5.

## Indications for use
ANDI is intended for the display of medical images and other healthcare data. It includes functions for processing MR images, atlas-assisted visualization, segmentation, and volumetric quantification of segmentable brain structures. The output is generated for use by a system capable of reading DICOM image sets. The information presented by ANDI does not provide prediction, diagnosis, or interpretation of brain health. Clinical interpretation and decision-making are the responsibility of the physician, who must review all clinical information associated with a patient in order to make a diagnosis and to determine the next steps in the clinical care of the patient. Typical users of ANDI are medical professionals, including but not limited to neurologists and radiologists. ANDI should be used only as adjunctive information. The decision made by trained medical professionals will be considered final.

Source page: https://510kreport.com/device/K261405
Methodology: https://510kreport.com/methodology