# K203279: Veuron-Brain-mN1

- Pathway: 510(k) (Traditional)
- Applicant: Heuron Co., Ltd.
- Decided: Jul 12, 2022 after 613 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: 10 generations back to K971684 (1997). 33 ancestors in all.
No later device cites it as a predicate yet.
9 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173224: Spin-Swi, Spintech, Inc. (2018) Summary page 4.

## Indications for use
Veuron-Brain-mN1 is intended for use in the post-acquisition image enhancement of 3T MR images of the brain acquired through a 3D gradient-echo sequence. When used in combination with other clinical information, the Veuron-Brain-mN1 application may aid the qualified radiologist with diagnosis by providing enhanced visualization of tissue structures with magnetic susceptibility contrasts in brain 3T MR images.

Source page: https://510kreport.com/device/K203279
Methodology: https://510kreport.com/methodology