OptimMRI

Primary DI
03770021895011
Brand
OptimMRI
Company
REBRAIN
Model
v1.2.0
Device description
OptimMRI is a software application for processing medical images of the brain that enables 3D visualization and analysis of anatomical structures. Specifically, the software can be used to read DICOM compatible pre-operative MR images acquired by commercially available imaging devices. These images can be processed to generate 3D markers in specific regions of the anatomy to allow qualified medical professionals to display, review, analyze, annotate, interpret, export, and plan neurosurgical functional procedures. OptimMRI is used as an aid to localize regions of the brain such as Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM).
Published
2023-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230150000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230150000OptimMRIRebrain, Sas2023-07-21QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03770021895011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770021895011037700218950113770021895011

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic system application softwareAn application software program intended to facilitate stereotactic treatment procedures (surgery or radiosurgery) by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, real-time surgical navigation and/or patient/procedure data management, image processing/transfer, and quality assurance. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
275535609
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770021895035OptimMRI (v2)v2.0.12024-10-22

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