Identifiers
- 510(k) Number
- K253057 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)
AI-Rad Companion Brain MR is a post-processing image analysis software designed for magnetic resonance (MR) brain imaging. It functions as a diagnostic aid by automating segmentation and analysis of brain structures, enhancing clinician workflows during image interpretation.
The device is supplied as software for use on compatible MR imaging systems and is intended for single-use per imaging session. It is not classified as a medical device requiring sterility or reusable processing. The software operates within MRI environments and has received FDA 510(k) clearance under the Radiology Advisory Committee. No additional regulatory markings or MRI safety classifications are specified.
Frequently asked questions
What is the AI-Rad Companion Brain MR used for in clinical practice?
The AI-Rad Companion Brain MR is designed as a diagnostic aid to automate segmentation and analysis of brain structures in MRI scans. It helps clinicians streamline workflows by providing automated image analysis, which can assist in interpreting brain MR images more efficiently.
How is the AI-Rad Companion Brain MR supplied, and is it reusable?
The AI-Rad Companion Brain MR is supplied as software for use on compatible MR imaging systems. It is intended for single-use per imaging session, meaning it is not designed for reuse or reprocessing like a physical medical device.
Does the AI-Rad Companion Brain MR require sterilization, and why?
No, the AI-Rad Companion Brain MR does not require sterilization because it is software-based and operates within MRI environments. Sterilization is only applicable to physical medical devices, and this software is not classified as one.
What regulatory pathway did the AI-Rad Companion Brain MR follow for FDA clearance?
The AI-Rad Companion Brain MR received FDA clearance through a Traditional 510(k) process under the Radiology Advisory Committee (RA). The decision was based on demonstrating substantial equivalence to a predicate device, as indicated by the decision_code: SESE and product_code: QIH.
Can this software be used with any MRI system, or are there specific compatibility requirements?
The AI-Rad Companion Brain MR is designed for use on compatible MR imaging systems, though the exact compatibility details (such as specific MRI vendors or models) are not specified in the provided data. Clinicians should verify system compatibility with Siemens Healthcare before integration.
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: AI-Rad Companion Brain MR - Siemens Healthineers Singapore, AI-Rad Companion - Siemens Healthineers, AI-Rad Companion Brain MR - Siemens Healthineers Singapore
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253057 | Class II | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
Sources (1)
- FDA 510(k) K253057 24 fields · synced Oct 6, 2026