# K112469: General Prupose Localizers and Adapters-New Accessories for Sonowand System

- Pathway: 510(k) (Traditional)
- Applicant: Sonowand AS
- Decided: Mar 23, 2012 after 210 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: 10 generations back to K935595 (1995). 32 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083597: Sonowand Invite, Sonowand AS (2009) Summary page 1.

## Most influential descendants
- K203251: SOLOPASS System (2021), 1 descendant of its own
- K251317: SOLOPASS 2.0 System (2025), 0 descendants of its own

## Indications for use
The Sonowand Invite System is intended for use as a tool to aid intraoperative ultrasound imaging and image guided surgery during neurosurgery. It is also intended for use as a standard neuronavigation system and as a stand-alone ultrasound scanner. The intended use of a localizer is to enable navigation by showing the position of surgical instruments or pointers relative to MR, CT or Ultrasound images The General purpose localizers with adapters are intended to be used to attach surgical tools manufactured by other vendors. SonoWand Invite System will display position and orientation of the tools in the medical images on the screen.

Source page: https://510kreport.com/device/K112469
Methodology: https://510kreport.com/methodology