# K023975: Voyager Linux

- Pathway: 510(k) (Special)
- Applicant: Z-Kat, Inc.
- Decided: Dec 20, 2002 after 18 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: 1 generation back to K000310 (2000). 1 ancestor in all.
172 later devices descend from it; 5 cite it directly.
0 of 174 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000310: Voyager 6.0 Software Option, Philips Medical Systems (Cleveland), Inc. (2000)

## Most influential descendants
- K031454: Acumen Surgical Navigation System (2004), 146 descendants of its own
- K050973: Modification to: Voyager Linux (2005), 97 descendants of its own
- K052851: Voyager Linux with Tactile Guidance System (TGS) (2005), 96 descendants of its own
- K031337: Acumen Surgical Navigation System (2003), 81 descendants of its own
- K072806: Mako Surgical Tactile Guidance System (TGS) (2008), 78 descendants of its own

## Indications for use
The Voyager is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures. The Voyager is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as: Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous) Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms ENT procedures Orthopedic surgical procedures

Source page: https://510kreport.com/device/K023975
Methodology: https://510kreport.com/methodology