Brainlab AG

Address:Olof-Palme-Strasse 9,Munich Bavaria,DE

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Planning, Radiation Therapy Treatment (MUJ) (5) Orthopedic Stereotaxic Instrument (OLO) (2) System, Image Processing, Radiological (LLZ) (2) Brain Stimulation Programming Planning Software. (QQC) (1)

Premarket Exempt

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INSTRUMENT SELECTION - 04056481142018 Catalog Number :

Device Description : Instrument selection software

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

Spine & Trauma 3D Navigation - 04056481142025 Catalog Number :

Device Description : Software for spine navigation

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

Brainlab Elements Guide XT, Guide 3.0 - 04056481142032 Catalog Number :

Device Description : Brainlab Elements Guide XT is a software application designed to support neurosu 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.

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : QQC

Prescription Use : Yes

Device Count : 1

RT Elements - Multiple Brain Mets SRS - 04056481142094 Catalog Number :

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : MUJ

Prescription Use : Yes

Device Count : 1

RT Elements - Cranial SRS - 04056481142100 Catalog Number :

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : MUJ

Prescription Use : Yes

Device Count : 1

RT Elements - Spine SRS - 04056481142117 Catalog Number :

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : MUJ

Prescription Use : Yes

Device Count : 1

RT Elements - RT QA - 04056481142124 Catalog Number :

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : MUJ

Prescription Use : Yes

Device Count : 1

RT Elements - Dose Review - 04056481142131 Catalog Number :

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : MUJ

Prescription Use : Yes

Device Count : 1

Brainlab Elements SmartBrush - 04056481142162 Catalog Number :

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Brainlab Elements Fibertracking - 04056481142186 Catalog Number :

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

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