510(k) · Cleared
ClearedNS-HGlio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neosoma, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Sep 27, 2022 as substantially equivalent to K170981 (Cortechs Labs, Inc., 2017) after a 104-day review. Its family tree reaches back 2 generations to 2006. 3 later devices descend from it.
- Decided
- Sep 27, 2022
- Review
- 104 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K061855 (2006). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK061855 NeuroquantCortechs Labs, Inc. · 2006
- 1 generation backK170981 NeuroQuantCortechs Labs, Inc. · 2017
- This deviceK221738 NS-HGlioNeosoma, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK260316 CMN Capillary Function with Oncology Virtual ExpertCercare Medical A/S · 2026
- Descendant · cites it directly · 0 of its ownK243863 Opulus™ Lymphoma PrecisionRoche Molecular Systems, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK233822 i2ContourMrimath, LLC · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K061855 | Neuroquant | Cortechs Labs, Inc. | 2006 | — |
| −1 | K170981 | NeuroQuant | Cortechs Labs, Inc. | 2017 | — |
| 0 (this device) | K221738 | NS-HGlio | Neosoma, Inc. | 2022 | — |
| +1 | K260316 | CMN Capillary Function with Oncology Virtual Expert | Cercare Medical A/S | 2026 | — |
| +1 | K243863 | Opulus™ Lymphoma Precision | Roche Molecular Systems, Inc. | 2025 | — |
| +1 | K233822 | i2Contour | Mrimath, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K170981 | NeuroQuantSummary page 4…FR 892.2050 Product Code QIH Regulatory Class II 1.3 Predicate Device Proprietary Name NeuroQuant Premarket Notification K170981 Classification Name Automated Radiological Image Processing Software Regulation Number 21 CFR 892.2050 Pro… | 2017 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 11.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K260316 (Cercare Medical A/S, 2026) has gone furthest, with 0 descendants of its own.
- 13 other devices also cite its predicate K170981.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K221738 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221738: NS-HGlio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221738
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026