← Back to catalogue
Brainlab Elements - Guide XT, 3.0
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 04056481142032
by Brainlab SE
Identity
- Trade Name
- Brainlab Elements - Guide XT, 3.0 EUDAMEDBrainlab Elements Guide XT, Guide 3.0 FDA UDI
- Generic Name
- Implantable electrical stimulation device management software FDA UDI
- Device Name
- Brainlab Elements - Guide XT EUDAMEDBrainlab Elements Guide XT is a software application designed to support neurosurgeons and neurologists in Deep Brain Stimulation (DBS) treatments. It enables stimulation field simulation and visualization of the stimulation field model in the context of anatomical images. This functionality can be used to aid in lead parameter adjustment in the context of minimally invasive cranial neurological procedures. Brainlab Elements Guide XT is used in combination with other applications that provide functionality for image fusion, segmentation, etc. Guide XT is compatible with selected Boston Scientific leads and implantable pulse Generators but does not directly interact with the surgeon. FDA UDI
- Model / Reference
- 04056481142032 EUDAMED3.0 FDA UDI
- Description
- Brainlab Elements Guide XT is a software application designed to support neurosurgeons and neurologists in Deep Brain Stimulation (DBS) treatments. It enables stimulation field simulation and visualization of the stimulation field model in the context of anatomical images. This functionality can be used to aid in lead parameter adjustment in the context of minimally invasive cranial neurological procedures. Brainlab Elements Guide XT is used in combination with other applications that provide functionality for image fusion, segmentation, etc. Guide XT is compatible with selected Boston Scientific leads and implantable pulse Generators but does not directly interact with the surgeon. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481142032 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04056481142032 EUDAMED
- FDA Product Code
- QQC FDA UDI
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Implantable electrical stimulation device management software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5855 FDA UDI
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Brainlab Elements - Guide XT, 3.0 by Brainlab SE — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213930 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04056481142032 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (3)
- EUDAMED 261c8f7b-83fe-4491-b4a1-828cec8714c0 61 fields · synced Jul 10, 2026
- FDA UDI e055faa9-d2f7-4827-8c5a-622fc4f0be96 33 fields · synced May 29, 2026
- FDA 510(k) K213930 1 fields · synced May 18, 2026