# K252670: Alzevita

- Pathway: 510(k) (Traditional)
- Applicant: Topia Medtech Limited
- Decided: Dec 19, 2025 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: 3 generations back to K061855 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220034: NEUROShield, In-Med Prognostics L3c (2023) Summary page 5.

## Indications for use
Alzevita is intended for use by neurologists and radiologists experienced in the interpretation and analysis of brain MRI scans. It enables automated labelling, visualization, and volumetric measurement of the hippocampus from high-resolution T1-weighted MRI images. The software facilitates comparison of hippocampal volume against a normative dataset derived from MRI scans of healthy control subjects aged 55 to 90 years, acquired using standardized imaging protocols on 1.5T/3T MRI scanners.

Source page: https://510kreport.com/device/K252670
Methodology: https://510kreport.com/methodology