# K180854: Voyager Trajectory Array Guide (V-TAG)

- Pathway: 510(k) (Traditional)
- Applicant: Voyager Therapeutics, Inc.
- Decided: Jul 23, 2018 after 112 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: 2 generations back to K992304 (1999). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090240: Monteris Medical Ufo, Monteris Medical, (2009) Summary page 4.

## Most influential descendants
- K250893: Ball Joint Guide Array (66295) (2025), 0 descendants of its own
- K191400: Voyager Trajectory Array Guide (V-TAG) (2019), 0 descendants of its own

## Indications for use
The V-TAG is intended to assist with stereotactic guidance, placement, and fixation for the operation of surgical instruments or devices during the planning and operation of neurological procedures performed in conjunction with preoperative and perioperative MR imaging. These procedures include laser coagulation, biopsies, catheter placement and electrode placement procedures.

Source page: https://510kreport.com/device/K180854
Methodology: https://510kreport.com/methodology