# K213645: ClearPoint Maestro Brain Model

- Pathway: 510(k) (Traditional)
- Applicant: ClearPoint Neuro, Inc.
- Decided: Aug 8, 2022 after 263 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: 1 generation back to K061855 (2006). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061855: Neuroquant, Cortechs Labs, Inc. (2006) Summary page 4.

## Most influential descendants
- K233243: ClearPoint System (Software Version 2.2) (2023), 1 descendant of its own
- K243657: ClearPoint System (Software Version 3.0) (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K213645
Methodology: https://510kreport.com/methodology