510(k) · Cleared
ClearedNeosoma Brain Mets
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 Dec 17, 2025 as substantially equivalent to K203235 (Vysioneer, Inc., 2021) after a 93-day review. Its family tree reaches back 16 generations to 1996. 1 of the 103 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 17, 2025
- Review
- 93 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K954874 (1996). 102 ancestors in all, the oldest K885054 (1989). No later device cites it as a predicate yet. 1 of the 103 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 12 generations between
- 3 generations backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- 2 generations backK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
- 1 generation backK203235 VBrainVysioneer, Inc. · 2021
- This deviceK252922 Neosoma Brain MetsNeosoma, Inc. · 2025
Show all 16 generations
- Root · 16 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 15 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 14 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 13 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 12 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 11 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 10 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 9 generations backK062163 MimviewerMimvista Corp. · 2006
- 8 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 7 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 6 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 5 generations backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- 4 generations backK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- 3 generations backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- 2 generations backK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
- 1 generation backK203235 VBrainVysioneer, Inc. · 2021
- This deviceK252922 Neosoma Brain MetsNeosoma, Inc. · 2025
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…5 generations back · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −15 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −14 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −13 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −12 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −11 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −10 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −9 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −8 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −7 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −6 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| −5 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| −4 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| −3 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| −2 | K191928 | AccuContour | Xiamen Manteia Technology, Ltd. | 2020 | — |
| −1 | K203235 | VBrain | Vysioneer, Inc. | 2021 | — |
| 0 (this device) | K252922 | Neosoma Brain Mets | Neosoma, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 1 |
| 2000 | 9 | 0 |
| 2001 | 6 | 0 |
| 2002 | 6 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 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.
1 device in this family has a Class I recall. 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.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · 5 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 31 of the 102 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K203235.
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. 2025, 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?
The Neosoma software uses an artificial intelligence algorithm (i.e., deep learning neural networks) to contour (segment) known or previously diagnosed brain tumors on MRI images for qualified and trained medical professionals. The technology is meant for informational purposes only and not intended to replace the clinician’s current standard practice of manual contouring. The software does not alter the original MRI image, nor is it intended to be used…
Read the full statement (151 words)
The Neosoma software uses an artificial intelligence algorithm (i.e., deep learning neural networks) to contour (segment) known or previously diagnosed brain tumors on MRI images for qualified and trained medical professionals.
The technology is meant for informational purposes only and not intended to replace the clinician’s current standard practice of manual contouring. The software does not alter the original MRI image, nor is it intended to be used to detect tumors for diagnosis. The software is intended to be used on adult patients only.
When using the Neosoma software in a radiation oncology planning workflow, or other clinical workflows, it is intended for generating Gross Tumor Volume (GTV) contours. For all clinical workflows, medical professionals must finalize (confirm or modify) the contours generated by the Neosoma software, as necessary, using an external platform available at the facility that supports DICOM viewing/editing functions, such as image visualization software and treatment planning system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252922 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252922: Neosoma Brain Mets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252922
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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