# K230913: ANDI

- Pathway: 510(k) (Traditional)
- Applicant: Imeka Solutions, Inc.
- Decided: Jul 25, 2023 after 116 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: 2 generations back to K081512 (2008). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203518: Quicktome, Omniscient Neurotechnology Pty Ltd (O8t) (2021) Summary page 4.

## Most influential descendants
- K252298: ANDI 2.0 (2025), 1 descendant of its own
- K261405: ANDI 2.2 (2026), 0 descendants of its own

## Indications for use
ANDI is intended for display of medical images and other healthcare data. It includes functions for image review, basic measurements, planning, and visualization (MPR reconstructions). Modules are available for image processing and atlas-assisted visualization and segmentation, where an output can be generated for use by a system capable of reading DICOM image sets. ANDI is indicated for use in the processing of diffusion-weighted MRI sequences into 3D maps that represent white matter tracts. The information presented by ANDI is for measurement of brain white matter tracts only without making a prediction, diagnosis, or interpretation of brain health. It is the responsibility of the physician to review all clinical information associated with a patient in order to make a diagnosis and to determine 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. It is not a diagnostic aid.

Source page: https://510kreport.com/device/K230913
Methodology: https://510kreport.com/methodology