# K233243: ClearPoint System (Software Version 2.2)

- Pathway: 510(k) (Traditional)
- Applicant: ClearPoint Neuro, Inc.
- Decided: Nov 27, 2023 after 60 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K031815 (2003). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222519: ClearPoint System, ClearPoint Neuro, Inc. (2022) Summary page 5.
- K213645: ClearPoint Maestro Brain Model, ClearPoint Neuro, Inc. (2022) Summary page 5.

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

## Indications for use
The ClearPoint System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. During planning, the system is intended to provide functionality for the automatic identification, labeling, visualization and quantification of segmentable brain structures from a set of loaded MR images. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion including deep brain stimulation (DBS) lead placement. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners and MR conditional implants and devices.

Source page: https://510kreport.com/device/K233243
Methodology: https://510kreport.com/methodology