# K243657: ClearPoint System (Software Version 3.0)

- Pathway: 510(k) (Traditional)
- Applicant: ClearPoint Neuro, Inc.
- Decided: Jan 24, 2025 after 58 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: 12 generations back to K031815 (2003). 25 ancestors in all.
No later device cites it as a predicate yet.
8 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233243: ClearPoint System (Software Version 2.2), ClearPoint Neuro, Inc. (2023) Summary page 5.
- K222519: ClearPoint System, ClearPoint Neuro, Inc. (2022) Summary page 5.
- K231976: StealthStation Cranial Software, v3.1.5 (9735585), Medtronic Navigation, Inc. (2023) Summary page 8.

## 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 an operating room environment and in conjunction with MR and/or CT 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) (asleep or awake) lead placement. When used in an MRI environment, 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/K243657
Methodology: https://510kreport.com/methodology