OptimMRI
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Rebrain, Sas
Identity
- Trade Name
- OptimMRI EUDAMEDOptimMRI (v2) FDA UDI
- Generic Name
- Stereotactic system application software FDA UDI
- Device Name
- OptimMRI EUDAMEDOptimMRI is a software application intended to aid qualified medical professionals in processing, visualizing, and interpreting anatomical structures from medical images. The software can be used to process pre-operative DICOM compatible MR images to generate 3D annotated models of the brain that aid the user in neurosurgical functional planning. The annotated MR images can further be used in conjunction with other clinical methods as an aid in localization of the Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM) regions of interest. FDA UDI
- Model / Reference
- v2 EUDAMEDv2.0.1 FDA UDI
- Description
- OptimMRI is a software application intended to aid qualified medical professionals in processing, visualizing, and interpreting anatomical structures from medical images. The software can be used to process pre-operative DICOM compatible MR images to generate 3D annotated models of the brain that aid the user in neurosurgical functional planning. The annotated MR images can further be used in conjunction with other clinical methods as an aid in localization of the Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM) regions of interest. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03770021895035 EUDAMEDFDA UDI
- Basic UDI-DI
- 3770021895OMRI14M EUDAMED
- FDA Product Code
- QIH FDA 510(k)FDA UDILLZ FDA UDI
- EMDN Code
- Z12100692 STEREOTACTIC NEUROSURGERY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Stereotactic system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Spain EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
OptimMRI is a magnetic resonance imaging (MRI) optimization device designed to enhance MRI scan quality and efficiency. It is classified under the product code QIH and falls within the Radiology advisory committee category, supporting diagnostic imaging workflows by refining signal processing and artifact reduction.
The device is supplied as a software-based solution, intended for use in MRI-compatible environments. It is intended for single-use or reusable configurations depending on the implementation, though no explicit sterility or reuse instructions are provided in the data. Authorized under FDA 510K clearance and MDR compliance, it operates within standard MRI safety guidelines without requiring special storage conditions.
Frequently asked questions
What types of MRI environments is the OptimMRI designed to work in and how does it improve scan quality?
The OptimMRI is a software-based solution designed specifically for MRI-compatible environments to enhance diagnostic imaging workflows. It improves scan quality by refining signal processing and reducing artifacts, which helps achieve clearer and more efficient MRI images. Since it operates within standard MRI safety guidelines, it can be integrated into existing MRI systems without requiring additional infrastructure.
Is the OptimMRI intended for single-use or reusable applications, and are there any special storage requirements?
The OptimMRI can be implemented in either single-use or reusable configurations, though the provided data does not specify explicit sterility or reuse instructions. It does not require special storage conditions, meaning it can be stored under standard environmental conditions without any additional precautions beyond typical MRI software maintenance.
What regulatory pathways has the OptimMRI undergone, and how does this affect its use in clinical settings?
The OptimMRI has undergone FDA 510(k) clearance and is compliant with the Medical Device Regulation (MDR). These pathways confirm that it meets regulatory standards for safety and effectiveness in diagnostic imaging. Clinicians can rely on its authorization to ensure it adheres to established guidelines for MRI optimization, though actual clinical use depends on local healthcare policies and institutional protocols.
How does the OptimMRI differ from traditional MRI systems in terms of its intended use and workflow integration?
Unlike traditional MRI hardware, the OptimMRI is a software-based solution that enhances existing MRI systems rather than replacing them. It focuses on refining signal processing and artifact reduction to improve scan quality and efficiency within diagnostic imaging workflows. This makes it a complementary tool for radiology departments seeking to optimize their current MRI infrastructure without major hardware upgrades.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K230150 | Class II | Active |
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Manufacturer
- Manufacturer
- Rebrain, Sas
Sources (3)
- FDA 510(k) K230150 24 fields · synced Sep 18, 2026
- FDA UDI 2d321444-5486-432c-bdcc-f301d22e9fb2 34 fields · synced May 30, 2026
- EUDAMED 6f81192e-8cad-4b22-91ab-2a4f31776938 61 fields · synced Jul 9, 2026