# K203142: Veuron-Brain-pAb

- Pathway: 510(k) (Traditional)
- Applicant: Heuron Co., Ltd.
- Decided: Jan 15, 2021 after 87 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: 7 generations back to K954874 (1996). 37 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121074: Scenium 2.0, Siemens Medical Solutions USA, Inc. (2012) Summary page 4.
- K060816: Mim 4.0 (Neuro, Mimvista Corp. (2006) Summary page 4.

## Most influential descendants
- K221405: Neurophet SCALE PET (2022), 2 descendants of its own
- K252496: Neurophet AQUA AD Plus (2026), 1 descendant of its own
- K213801: Veuron-Brain-pAb2 (2022), 1 descendant of its own
- K252563: Neurophet SCALE PET (2026), 0 descendants of its own
- K231642: Veuron-Brain-pAb3 (2023), 0 descendants of its own

## Indications for use
The Veuron-Brain-pAb 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 radio-tracer and disease combinations.

Source page: https://510kreport.com/device/K203142
Methodology: https://510kreport.com/methodology