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Ultrasound Navigation, 1.2

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 04056481144630

by Brainlab SE

Identity

Trade Name
Ultrasound Navigation, 1.2 EUDAMED
Ultrasound Navigation FDA UDI
Generic Name
Electromagnetic/optical surgical navigation device tracking system FDA UDI
Device Name
Ultrasound Navigation EUDAMED
Ultrasound Navigation 1.2 is software that runs on a Brainlab IGS platform or Brainlab navigation system which consists of a computer, a display and an infrared (IR) tracking camera. It can be used in conjunction with other Brainlab Image Guided Surgery (IGS) software. Designed to assist during surgeries, it provides intraoperative ultrasound functionality by: - Linking the 2D ultrasound view to preoperative patient image data by overlaying the 2D ultrasound image with the patient image data (e.g., CT/MR and derived data such as segmented objects, fibers, etc.). - Acquiring 3D ultrasound data sets consisting of 2D ultrasound image slices and enabling navigation and viewing with other Brainlab IGS software, as well as further processing of this data. FDA UDI
Model / Reference
04056481144630 EUDAMED
1.2 FDA UDI
Description
Ultrasound Navigation 1.2 is software that runs on a Brainlab IGS platform or Brainlab navigation system which consists of a computer, a display and an infrared (IR) tracking camera. It can be used in conjunction with other Brainlab Image Guided Surgery (IGS) software. Designed to assist during surgeries, it provides intraoperative ultrasound functionality by: - Linking the 2D ultrasound view to preoperative patient image data by overlaying the 2D ultrasound image with the patient image data (e.g., CT/MR and derived data such as segmented objects, fibers, etc.). - Acquiring 3D ultrasound data sets consisting of 2D ultrasound image slices and enabling navigation and viewing with other Brainlab IGS software, as well as further processing of this data. FDA UDI

Identifiers

Primary DI / UDI-DI
04056481144630 EUDAMEDFDA UDI
Basic UDI-DI
4056481UltrasoundNavi53 EUDAMED
FDA Product Code
HAW FDA UDI
EMDN Code
Z12011482 SURGICAL NAVIGATION INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
GMDN Term
Electromagnetic/optical surgical navigation device tracking system FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
Special Device Type
Software 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

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Ultrasound Navigation, 1.2 by Brainlab SE — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Brainlab SE
EUDAMED SRN
DE-MF-000006183

Sources (2)

  • EUDAMED 5febd307-6fb8-4347-89d6-88bde5e75e2c 61 fields · synced Jul 9, 2026
  • FDA UDI 5ddea436-66df-454d-b280-139f9bf9e0d7 33 fields · synced May 30, 2026