Ultrasound Navigation

GUDID 04056481144630

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.

Brainlab AG

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Primary Device ID04056481144630
NIH Device Record Key5ddea436-66df-454d-b280-139f9bf9e0d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltrasound Navigation
Version Model Number1.2
Company DUNS314482980
Company NameBrainlab AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481144630 [Primary]

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-06
Device Publish Date2024-04-26

On-Brand Devices [Ultrasound Navigation]

040564811401371.0
04056481144630Ultrasound Navigation 1.2 is software that runs on a Brainlab IGS platform or Brainlab navigatio
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