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Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K252358Ref NX92523

by Nexstim Oyj

Identity

Trade Name
Navigated Brain Stimulation System EUDAMED
Nexstim NBS System FDA UDI
Generic Name
Stereotactic neuronavigation/planning system FDA UDI
Device Name
Nexstim Navigated Brain Stimulation System EUDAMED
Nexstim NBS System FDA UDI
Model / Reference
NX92523 EUDAMED
5 FDA UDI
Description
Nexstim NBS System FDA UDI

Identifiers

Primary DI / UDI-DI
06430063200057 EUDAMEDFDA UDI
Basic UDI-DI
B-06430063200057 EUDAMED
510(k) Number
K252358 FDA 510(k)
K112881 FDA UDI
FDA Product Code
OBP FDA 510(k)
GWF FDA UDI
IKN FDA UDI
HAW FDA UDI
EMDN Code
Z12101106 NEUROLOGICAL STIMULATORS EUDAMED
GMDN Term
Stereotactic neuronavigation/planning system FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 882.5805 FDA 510(k)
Regulation Number
882.5805 FDA 510(k)
882.1870 FDA UDI
890.1375 FDA UDI
882.4560 FDA UDI
Market of Registration
Finland EUDAMED
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

The Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) is a Transcranial Magnetic Stimulator, designed for non-invasive brain stimulation and mapping. It employs navigated brain stimulation technology to deliver precise, targeted magnetic pulses to specific cortical regions, facilitating functional mapping and therapeutic interventions in neurology.

The system is intended for use in clinical settings, including hospitals and research facilities, and is supplied as a reusable medical device. It operates under FDA 510(k) clearance and EU MDR compliance, with multiple registration numbers reflecting its classification as a Class II device. The system requires proper calibration and adherence to manufacturer guidelines for safe and effective use, with no indication of MRI compatibility or single-use specifications.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nexstim Oyj

Sources (3)

  • FDA 510(k) K252358 24 fields · synced Sep 18, 2026
  • FDA UDI 81b2ba0e-7172-4ad6-96b7-d0318dc719b5 35 fields · synced May 30, 2026
  • EUDAMED 33fb3925-fa40-4a7b-bb1a-68fb15b4d0c7 61 fields · synced Aug 1, 2026