# K030764: Z-BOX

- Pathway: 510(k) (Special)
- Applicant: Z-Kat, Inc.
- Decided: Apr 24, 2003 after 44 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 K000310 (2000). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023975: Voyager Linux, Z-Kat, Inc. (2002)

## Most influential descendants
- K051724: Acumen Image Guided Surgical System (2005), 0 descendants of its own
- K031732: Ebi Acumen Surgical Navigation System (2003), 0 descendants of its own

## Indications for use
2-Box 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. 2-Box 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 procedure

Source page: https://510kreport.com/device/K030764
Methodology: https://510kreport.com/methodology