AI-Rad Companion Brain MR
AI-Rad Companion Brain MR is post-processing software for viewing and analyzing brain MR images. It automatically segments individual brain structures, calculates their volumes and compares…
AI-Rad Companion Brain MR is post-processing software for viewing and analyzing brain MR images. It automatically segments individual brain structures, calculates their volumes and compares those measurements with a normative database. Results are presented as numerical values and graphics.
The software can generate a report that marks deviations from the normative database, and results can be transferred to PACS depending on configuration. It processes images after acquisition; the scanner creates the underlying MR images.
Volumetric Analysis
The software identifies brain structures in MR images and measures each structure’s volume. Comparisons with a normative database are displayed as deviation maps and reported measurements for clinician review.
Siemens describes Brain MR as decision support for image interpretation. The outputs are analytical aids within a clinical workflow and do not replace professional assessment.
Who Else Makes It
Concentrated in Beijing (4), Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Ultrasound (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 4 |
| Wuhan United Imaging Healthcare Co., Ltd. | Wuhan | Hubei | Manufacturer | 4 |
| Keya Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Siemens Healthcare Limited, Canada |
|---|---|
| FDA product code | QIH |
| Device type | Automated Radiological Image Processing Software |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K232305 |
| Record published | 2023-11-21 |
| Record revised | 2023-12-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11665399 | In distribution | |
| 11830481 | In distribution | |
| 11582982 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Imbio RV/LV | Imbio, LLC | 5 |
| VEA Align | EOS imaging | 4 |
| Qlab Advanced Quantification Software | Philips Ultrasound LLC | 3 |
| uOmnispace | Shanghai United Imaging Healthcare Co., Ltd. | 3 |
| Scenium | Siemens Medical Solutions USA, Inc. | 3 |
| syngo.MI General | Siemens Medical Solutions USA, Inc. | 3 |
| Neosoma Dashboard | Neosoma, Inc. | 3 |
| BriefCase-Quantification | Aidoc Medical Ltd. | 3 |
| OrthoNext™ Platform System Software | Orthofix SRL | 3 |
| MI View&GO | Siemens Medical Solutions USA, Inc. | 3 |
| FEops | Feops NV | 3 |
| Tomtec-Arena | Tomtec Imaging Systems GMBH | 3 |
Showing 12 of 147. All products under Automated Radiological Image Processing Software
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253689 | 2026-04-10 |
| K253057 | 2026-01-22 |
| K242551 | 2025-04-03 |
| K232856 | 2023-12-01 |
| K213706 | 2022-04-15 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.