# K983539: Trajectory Guide, Model # TGX-XXX

- Pathway: 510(k) (Traditional)
- Applicant: Image-Guided Neurologics, Inc.
- Decided: Feb 12, 1999 after 126 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Trajectory Guide 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. The Trajectory Guide is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include catheter placement and electrode implant. The device will provide accurate delivery of devices or instruments to target sites 3mm and larger.

Source page: https://510kreport.com/device/K983539
Methodology: https://510kreport.com/methodology