# K221738: NS-HGlio

- Pathway: 510(k) (Traditional)
- Applicant: Neosoma, Inc.
- Decided: Sep 27, 2022 after 104 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: 2 generations back to K061855 (2006). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170981: NeuroQuant, Cortechs Labs, Inc. (2017) Summary page 4.

## Most influential descendants
- K260316: CMN Capillary Function with Oncology Virtual Expert (2026), 0 descendants of its own
- K243863: Opulus™ Lymphoma Precision (2025), 0 descendants of its own
- K233822: i2Contour (2024), 0 descendants of its own

## Indications for use
NS-HGlio is intended for the semi-automatic labeling, visualization, and volumetric quantification of high-grade brain glioma (WHO grade 3 astrocytoma, WHO grade 4 astrocytoma and WHO grade 4 glioblastoma) from a set of standard MRI images of male or female patients 18 years of age or older who are known to have pathologically proven high-grade glioma. Volumetric measurements may be compared to past measurements if available. NS-HGlio is not to be used for primary diagnosis, and is intended to be used by qualified clinical personnel as an additional source of information and is not intended to be the sole diagnostic metric.

Source page: https://510kreport.com/device/K221738
Methodology: https://510kreport.com/methodology