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AI4CMR v1.0

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K220624

by AI4MedImaging Medical Solutions S.A.

Identifiers

510(k) Number
K220624 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)

AI4CMR v1.0 is a software-as-a-medical-device (SaMD) designed for cardiac magnetic resonance (CMR) imaging analysis. It automates the segmentation and quantification of cardiac structures from CMR scans, aiding in the assessment of cardiac anatomy and function.

The device is intended for use in clinical settings by radiologists or cardiologists to streamline post-processing workflows. Supplied as a digital solution, it operates on compatible imaging platforms and requires no physical sterilisation. Authorised under FDA 510(k) clearance (K220624) and MDR compliance, it adheres to regulatory standards for SaMD in radiology applications.

Frequently asked questions

What clinical role does AI4CMR v1.0 play in cardiac imaging workflows and who is it intended for?

AI4CMR v1.0 is designed to automate the segmentation and quantification of cardiac structures from cardiac magnetic resonance (CMR) scans, helping radiologists and cardiologists assess cardiac anatomy and function more efficiently. It streamlines post-processing workflows by reducing manual effort in analyzing CMR images, making it ideal for clinical settings where quick and accurate cardiac evaluations are critical.

How is AI4CMR v1.0 supplied and does it require any physical sterilization?

AI4CMR v1.0 is supplied as a digital software solution and does not require physical sterilization. Since it operates on compatible imaging platforms, there are no physical components that need sterilization, simplifying its integration into existing clinical workflows.

Is AI4CMR v1.0 intended for single-use or repeated use across multiple patients?

AI4CMR v1.0 is a software solution intended for repeated use across multiple patients. As a digital tool, it remains functional for ongoing clinical applications without the constraints of single-use limitations, provided it is maintained and updated according to manufacturer guidelines.

What regulatory pathways does AI4CMR v1.0 follow, and how does this affect its use?

AI4CMR v1.0 is authorized under both FDA 510(k) clearance (K220624) and MDR compliance, ensuring it meets regulatory standards for software-as-a-medical-device (SaMD) in radiology. This means it has undergone evaluation to demonstrate substantial equivalence to existing devices in the radiology category, providing confidence in its safety and performance for clinical use.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
AI4MedImaging Medical Solutions S.A.

Sources (2)

  • FDA 510(k) K220624 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026