# K193287: CorInsights MRI

- Pathway: 510(k) (Traditional)
- Applicant: Adm Diagnostics, Inc.
- Decided: Nov 20, 2020 after 359 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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 K061855 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170981: NeuroQuant, Cortechs Labs, Inc. (2017) Summary page 4.

## Indications for use
The Corlnsights MRI Medical Image Processing Software is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from MRI images. Volumetric measurements are compared to reference percentile data. Corlnsights MRI is for adults age 45 to 95.

Source page: https://510kreport.com/device/K193287
Methodology: https://510kreport.com/methodology