510(k) · Cleared
ClearedClearPoint Maestro Brain Model
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ClearPoint Neuro, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Aug 8, 2022 as substantially equivalent to K061855 (Cortechs Labs, Inc., 2006) after a 263-day review. Its family tree reaches back 1 generation to 2006. 2 later devices descend from it.
- Decided
- Aug 8, 2022
- Review
- 263 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K061855 (2006). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK061855 NeuroquantCortechs Labs, Inc. · 2006
- This deviceK213645 ClearPoint Maestro Brain ModelClearPoint Neuro, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK233243 ClearPoint System (Software Version 2.2)ClearPoint Neuro, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK243657 ClearPoint System (Software Version 3.0)ClearPoint Neuro, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K061855 | Neuroquant | Cortechs Labs, Inc. | 2006 | — |
| 0 (this device) | K213645 | ClearPoint Maestro Brain Model | ClearPoint Neuro, Inc. | 2022 | — |
| +1 | K233243 | ClearPoint System (Software Version 2.2) | ClearPoint Neuro, Inc. | 2023 | — |
| +2 | K243657 | ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 23.6 · 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 |
|---|---|---|---|
| * | K061855 | NeuroquantSummary page 4…ation Name: Medical Image Management and Processing System (892.2050) Regulatory Class: Class II Product Code: QIH Predicate Devices CorTech Labs, Inc. - NeuroQuant (K061855) Device Description The ClearPoint MaestroTM Brain Model provides automated image processing of brain structures from T1-weight… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233243 | ClearPoint System (Software Version 2.2) | 2023 | 1 |
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?
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?
ClearPoint Maestro™ Brain Model is intended for automatic labeling, visualization, volumetric and shape quantification of segmentable brain structures from a set of MR images. This software is intended to automate the process of identifying, labelling, and quantifying the volume and shape of brain structures visible in MRI images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213645 · printed Nov 3, 2026
Cite this page
510(k) Report. “K213645: ClearPoint Maestro Brain Model.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K213645
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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