OptimMRI (v2)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Rebrain, Sas
Identifiers
- 510(k) Number
- K242054 FDA 510(k)
- FDA Product Code
- QIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
OptimMRI (v2) is an AI-enabled Automated Radiological Image Processing Software designed for automated analysis of MRI scans. It leverages machine learning to identify and delineate regions of interest within brain imaging, supporting precise preoperative planning and surgical targeting.
This device is supplied as Software as a Medical Device (SaMD) and is intended for use in radiology workflows, requiring MRI-compatible hardware for image acquisition. It is classified as Class II under Special Controls and has received FDA 510(k) clearance (K242054) and MDR authorization. The device is non-sterile, reusable, and operates within the QIH product code category for automated radiological processing systems.
Frequently asked questions
What types of MRI scans is OptimMRI (v2) designed to analyze, and how does it assist in preoperative planning?
OptimMRI (v2) is designed to analyze brain MRI scans, using AI-driven automated processing to identify and delineate regions of interest. This helps clinicians achieve precise preoperative planning and surgical targeting by streamlining the analysis of critical anatomical structures, reducing manual effort, and improving accuracy in radiology workflows.
Is OptimMRI (v2) a single-use or reusable device, and what are its storage requirements?
OptimMRI (v2) is a reusable software-based medical device, not a physical consumable. Since it is non-sterile and operates on MRI-compatible hardware, storage requirements are minimal—it simply needs to be installed on compliant radiology systems and maintained according to standard IT and software best practices to ensure optimal performance.
How does a clinician determine if their MRI system is compatible with OptimMRI (v2)?
OptimMRI (v2) requires MRI-compatible hardware for image acquisition, but the software itself does not specify exact hardware models. Clinicians should verify compatibility by checking if their MRI system can generate DICOM-formatted images, as the software processes these files for analysis. The manufacturer’s documentation or support team can provide further guidance on integration.
What regulatory pathways has OptimMRI (v2) followed, and what does this mean for its use in clinical settings?
OptimMRI (v2) has received FDA 510(k) clearance (K242054) and MDR authorization, confirming it meets regulatory standards for AI-enabled radiological software. This means it can be legally used in clinical settings in the U.S. and EU, provided it is deployed on compliant MRI systems and adheres to the manufacturer’s instructions for safe and effective operation.
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. Sources consulted: Home - Rebrain, Rebrain, SAS: OptimMRI (v2) (FDA-cleared AI medical device), K242054 FDA 510(k) - OptimMRI (v2) | Rebrain, Sas, PDF for using annotated MR image - rebrain.eu
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 | K242054 | Class II | Active |
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Manufacturer
- Manufacturer
- Rebrain, Sas
Sources (2)
- FDA 510(k) K242054 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026