# K981508: Vectorvision Spine Module

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Oct 29, 1998 after 185 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.
145 later devices descend from it; 1 cites it directly.
3 of 146 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
- K024192: Vectorvision FLUORO3D (2003), 144 descendants of its own
- K070106: VV Fluoro 3D (2007), 119 descendants of its own
- K062086: Navivision (2006), 77 descendants of its own
- K081386: Model 6150 (MYLAB70) and Model 6100 (MYLAB90) (2008), 53 descendants of its own
- K091009: MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60, Model 6150 (2009), 51 descendants of its own

## Indications for use
BrainLAB VectorVision Spine Module i¢ intended to be an intraoperative image guided localization system to enable open or percutaneous surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient’s images data being processed by a BrainSCAN workstation (K915819). The system is indicated for any medical condition where a reference to a rigid anatomical structire, such as the skull, a long bone or vertebra can be identified relative ta a (71" hased model of the anatomy where surgically appropriate.

Source page: https://510kreport.com/device/K981508
Methodology: https://510kreport.com/methodology