# K213801: Veuron-Brain-pAb2

- Pathway: 510(k) (Traditional)
- Applicant: Heuron Co., Ltd.
- Decided: Feb 4, 2022 after 60 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: 8 generations back to K954874 (1996). 38 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203142: Veuron-Brain-pAb, Heuron Co., Ltd. (2021) Summary page 4.

## Most influential descendants
- K231642: Veuron-Brain-pAb3 (2023), 0 descendants of its own

## Indications for use
The Veuron-Brain-pAb2 is a software for the registration, fusion, display and analysis of medical images from multiple modalities including MRI and PET. The software aids clinician in the assessment and quantification of pathologies from PET Amyloid scans of the human brain. It enables automatic analysis and visualization of amyloid protein concentration through the calculation of standard uptake volume ratios (SUVR) within target regions of interest and comparison to those within the reference regions. The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with radiotracer and disease combinations.

Source page: https://510kreport.com/device/K213801
Methodology: https://510kreport.com/methodology