# K210109: visor2 system

- Pathway: 510(k) (Traditional)
- Applicant: Eemagine Medical Imaging Solutions GmbH
- Decided: Apr 8, 2022 after 444 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: 7 generations back to DEN070003 (2008). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191422: Neural Navigator, Soterix Medical, Inc. (2020) Summary page 4.

## Most influential descendants
- K261228: QuickVision Ultimate rTMS (2026), 0 descendants of its own

## Indications for use
visor2 is used to aid 3D navigation for positioning of Transcranial Magnetic Stimulation (TMS) coils over preselected brain regions based on data from MRI measurements or scalp landmarks and optional EMG recording in clinical procedures. The visor2 system is compatible with the following commercially available TMS coils of the following TMS companies: • Mag & More: PMD70-aCool Double coil Figure-8 (510575) • MagStim Company Ltd.: Double 70mm Remote Coil (3190-00 rev2), Double 70mm Air Film Coil (3910 00); • MagVenture A/S: Double 75mm (C-B60), Double Cooled 75mm (Cool-B65), Double 95mm (D-B80), Angulated Double Cooled 97mm (Cool-B70 rev2), Butterfly figure-8 (C-B70) • Neuronetics Inc.: NeuroStar coil The visor2 system must be operated by a trained physician and must not be used during surgical operations.

Source page: https://510kreport.com/device/K210109
Methodology: https://510kreport.com/methodology