# K962939: Vectorvision

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab, Inc.
- Decided: May 22, 1997 after 297 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.
153 later devices descend from it; 2 cite it directly.
0 of 154 devices 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.

## Most influential descendants
- K013025: Modification to Flourolab Plus (2001), 151 descendants of its own
- K031454: Acumen Surgical Navigation System (2004), 146 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
- K081867: Mako Surgical Tactile Guidance System Version 2.0 (2008), 76 descendants of its own

## Indications for use
Frameless stereotactic cranial neurosurgery and intraoperative surgical guidance.

Source page: https://510kreport.com/device/K962939
Methodology: https://510kreport.com/methodology