# K213930: Brainlab Elements Guide XT, Guide 3.0

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Apr 19, 2022 after 124 days
- Product code: QQC (Brain Stimulation Programming Planning Software.)
- Device class: 2
- Regulation: 21 CFR 882.5855
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN210003 (2021). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN210003: SureTune4 Software, Medtronic Neuromodulation (2021) Summary page 4.

## Indications for use
Brainlab Elements Guide XT provides functionality to assist medical professionals in planning the programming of stimulation for patients receiving approved Boston Scientific deep brain stimulation (DBS) devices.

Source page: https://510kreport.com/device/K213930
Methodology: https://510kreport.com/methodology