# K232644: neuro42 MRI System

- Pathway: 510(k) (Traditional)
- Applicant: Neuro42, Inc.
- Decided: Feb 8, 2024 after 162 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K001773 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192002: Lucy Point-of-Care Magnetic Resonance Imaging Device, Hyperfine Research, Inc. (2020) Summary page 5.

## Indications for use
The neuro42 Magnetic Resonance Imaging System is a bedside magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, the images can provide diagnostically useful information.

Source page: https://510kreport.com/device/K232644
Methodology: https://510kreport.com/methodology