Automatic Registration iMRI

GUDID 04056481144845

Automatic Registration iMRI provides an automatic image registration for cranial indications.

Brainlab AG

Electromagnetic/optical surgical navigation device tracking system
Primary Device ID04056481144845
NIH Device Record Key7a936644-c20f-4ab1-8154-a13181cabe5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutomatic Registration iMRI
Version Model Number1.1
Company DUNS314482980
Company NameBrainlab AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS104056481144845 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2023-11-28
Device Publish Date2023-11-20

Devices Manufactured by Brainlab AG

04056481145514 - Z-touch Laser Registration Pointer2025-02-21 The Z-touch Laser Registration Pointer is a battery powered wireless laser pointer for quick and accurate patient registration w
04056481144906 - Spine &Trauma Navigation2024-11-22
04056481146238 - PATIENT REFERENCE ARRAY SPINE & TRAUMA2024-11-22
04056481146603 - ADAPTER SHORT FOR PATIENT REFERENCE CLAMP2024-11-22
04056481146610 - ADAPTER X-PRESS FOR PATIENT REFERENCE ARRAY2024-11-22
04056481143916 - Spine Planning2024-11-13
04056481144654 - Viewer 5.42024-11-13
04056481143527 - DICOM Proxy2024-11-01

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