# K223268: BrainInsight

- Pathway: 510(k) (Traditional)
- Applicant: Hyperfine, Inc.
- Decided: Dec 16, 2022 after 53 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 K061855 (2006). 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)
- K220815: BrainInsight, Hyperfine, Inc. (2022) Summary page 4.

## Indications for use
BrainInsight is intended for automatic labeling, spatial measurement, and volumetric quantification of brain structures from a set of low-field MR images and returns annotated and segmented images, color overlays and reports.

Source page: https://510kreport.com/device/K223268
Methodology: https://510kreport.com/methodology