# K083597: Sonowand Invite

- Pathway: 510(k) (Traditional)
- Applicant: Sonowand AS
- Decided: Sep 25, 2009 after 294 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: 9 generations back to K935595 (1995). 31 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K023651: Vectorvision Cranial/Ent, Brainlab AG (2004) Summary page 1.
- K061525: GE Vivid - I, General Electric Co. (2006) Summary page 1.
- K072365: Sequoia Plus Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc., Ultrasound DI (2007) Summary page 1.

## Most influential descendants
- K112469: General Prupose Localizers and Adapters-New Accessories for Sonowand System (2012), 2 descendants of its own
- 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 is intended for use as a tool to aid intraoperative ultrasound imaging and image guided surgery during neurosurgery. The Sonowand is intended for use as a standard neuronavigation system. The Sonowand is intended for use as a stand-alone ultrasound scanner.

Source page: https://510kreport.com/device/K083597
Methodology: https://510kreport.com/methodology