AI-Rad Companion Prostate MR
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252608 FDA 510(k)
- FDA Product Code
- LLZ 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)
The AI-Rad Companion Prostate MR is an artificial intelligence-powered software application designed for automated segmentation and analysis of prostate MRI scans. It aids radiologists in delineating the prostate gland’s outer contour, calculating gland volume, and identifying potential biopsy targets for MR/US-fusion procedures, streamlining diagnostic workflows.
This software is intended for use in radiology settings with multiparametric MRI systems, facilitating seamless integration with urologist workflows. Supplied as a non-sterile, reusable digital tool, it operates within MRI-safe environments and requires no specific storage conditions. Authorised under FDA 510(k) and MDR compliance, it is classified under product code LLZ and k-number K252608.
Frequently asked questions
What clinical workflows does the AI-Rad Companion Prostate MR software support in radiology settings?
The AI-Rad Companion Prostate MR is designed to assist radiologists in analyzing multiparametric MRI scans of the prostate. It automates segmentation of the prostate gland’s outer contour, calculates gland volume, and helps identify potential biopsy targets for MR/US-fusion procedures. This integration streamlines workflows by reducing manual delineation time and improving consistency in diagnostic assessments.
Is the AI-Rad Companion Prostate MR software single-use or reusable, and what are its storage requirements?
The AI-Rad Companion Prostate MR is a reusable digital tool, not a physical consumable. Since it is non-sterile and software-based, it does not require specialized storage conditions—standard IT infrastructure and MRI-safe environments are sufficient. No expiration or sterilization protocols apply.
How does the AI-Rad Companion Prostate MR integrate with existing MRI systems, and what types of MRI systems is it compatible with?
The software is intended for use with multiparametric MRI systems commonly found in radiology settings. It integrates as a digital application within these systems to analyze prostate MRI scans, enabling seamless workflows between radiologists and urologists. Compatibility is tied to the system’s ability to support AI-powered segmentation tools for prostate imaging.
What regulatory pathways does the AI-Rad Companion Prostate MR follow, and how does this affect its use in clinical practice?
The AI-Rad Companion Prostate MR is authorized under both FDA 510(k) clearance and MDR compliance, indicating it meets regulatory standards for safety and performance in the U.S. and EU markets. This approval allows clinicians to use it confidently in diagnostic workflows, ensuring it adheres to established guidelines for AI-assisted medical imaging tools in radiology.
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 Prostate MR - Siemens Healthineers, AI-Rad Companion - Siemens Healthineers, AI-Rad Companion Prostate MR - Siemens Healthineers
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 | K252608 | Class II | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
Sources (2)
- FDA 510(k) K252608 24 fields · synced Oct 7, 2026
- EUDAMED 1 fields · synced Jul 26, 2026