Brainlab AG

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

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Filters

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

Accelerator, Linear, Medical (IYE) (5) Orthopedic Stereotaxic Instrument (OLO) (4) System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

No Yes

Clear

Viewer - 04056481143800 Catalog Number :

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Registration Fluoro 3D - 04056481143923 Catalog Number :

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

C-ARM ADAPTER GE OEC 3D LEFT - 04056481143930 Catalog Number :

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

C-ARM ADAPTER GE OEC 3D RIGHT - 04056481143947 Catalog Number :

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

Spine & Trauma Navigation - 04056481143954 Catalog Number :

Device Description : Spine & Trauma Navigation is intended as an intraoperative image-guided localiza Spine & Trauma Navigation is intended as an intraoperative image-guided localization system to enable open and minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 2D or 3D image data.Spine & Trauma Navigation enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system. The software offers screw and interbody device planning and navigation with surgical instruments.The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 3D fluoroscopic image reconstruction or 2D fluoroscopic image) and/or an image data based model of the anatomy.

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ExacTrac Dynamic - 04056481143978 Catalog Number :

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

CRANIAL 4PI HEADREST INLAY H&N 2PCS - 04056481144180 Catalog Number :

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

CRANIAL 4PI HEADREST INLAY OPENFACE 2PCS - 04056481144197 Catalog Number :

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

CRANIAL 4PI HEADREST INLAY STANDARD 2PCS - 04056481144203 Catalog Number :

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

CRANIAL 4PI HEADREST LOW-NECK - 04056481144210 Catalog Number :

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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