# K221544: MagVenture TMS Atlas Neuro Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Tonica Elektronik A/S
- Decided: Mar 17, 2023 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: 7 generations back to DEN070003 (2008). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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 5.

## Indications for use
The MagVenture TMS Atlas Neuro Navigation System is a neuronavigation system indicated for accurate positioning of the treatment coil of the MagVenture TMS Therapy system with respect to target brain regions based on data obtained from MRI measurements. Specifically, the MagVenture TMS Atlas Neuro Navigation System is indicated for use with the following MagVenture treatment coils manufactured by Tonica Elektronik A/S: C-B60, Cool-B65, Cool-B70, Cool DB80, MCF-B65, MCF-B70, and C-B70.

Source page: https://510kreport.com/device/K221544
Methodology: https://510kreport.com/methodology