Identifiers
- 510(k) Number
- K252084 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)
AI4CMR v2.0 is an AI-enabled software device designed for cardiac magnetic resonance (CMR) imaging analysis. It automates image interpretation and reporting to enhance diagnostic efficiency and accuracy in radiology settings, reducing manual workload and enabling faster clinical decision-making.
The device is supplied as a digital solution for use on compatible MRI systems, requiring no additional hardware. It is classified under the MDR and holds FDA 510(k) clearance (K252084) with a special review designation. AI4CMR v2.0 operates as a single-use software application per imaging session, with no sterility or physical packaging requirements, and is intended for use in regulated healthcare environments.
Frequently asked questions
What types of MRI systems is the AI4CMR v2.0 designed to work with, and how is it supplied to the clinic?
The AI4CMR v2.0 is a digital software solution that integrates with compatible cardiac magnetic resonance (CMR) MRI systems, requiring no additional hardware. It is supplied as a standalone software application, meaning no physical packaging or sterility considerations apply—it is activated per imaging session and operates as a single-use tool within the radiology workflow.
Is the AI4CMR v2.0 reusable across multiple patients, or is it intended for one-time use per scan session?
The AI4CMR v2.0 is designed for single-use per imaging session, meaning it is activated for one CMR scan analysis and reporting cycle. Since it is software-based and does not involve physical components, there is no need for reprocessing or reuse between patients.
What regulatory pathways has AI4CMR v2.0 followed, and what does the special review designation mean for its approval?
AI4CMR v2.0 has undergone FDA 510(k) clearance (K252084) with a special review designation, indicating it was evaluated by the FDA’s Radiology (RA) Advisory Committee. It is also compliant with the EU Medical Device Regulation (MDR). The special review suggests the device was deemed substantially equivalent to a predicate, with additional scrutiny from the advisory committee.
How does the AI4CMR v2.0 reduce manual workload in radiology, and what clinical benefits does it provide?
AI4CMR v2.0 automates image interpretation and reporting in CMR scans, streamlining workflows by reducing the time radiologists spend on manual analysis. This enhances diagnostic efficiency and accuracy, enabling faster clinical decision-making while minimizing human error in interpreting cardiac MRI results.
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: AI4Medimaging - AI4CMR - Cardiac MRI Simplified, PDF Version 2.0 USER MANUAL - ai4cmr.com, Ai4medimaging Medical Solutions S.A.: AI4CMR v2.0 (FDA-cleared AI ..., PDF Ai4medimaging Medical Solutions S.A. ℅ Sandra Soniec
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 | K252084 | Class II | Active |
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Manufacturer
- Manufacturer
- AI4MedImaging Medical Solutions S.A.
Sources (2)
- FDA 510(k) K252084 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026