# K252084: AI4CMR v2.0

- Pathway: 510(k) (Special)
- Applicant: Ai4medimaging Medical Solutions S.A.
- Decided: Feb 11, 2026 after 224 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K945512 (1995). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220624: AI4CMR v1.0, Ai4medimaging Medical Solutions S.A. (2022) Summary page 5.

## Indications for use
AI4CMR software is designed to report cardiac function measurements (ventricle volumes, ejection fraction, indices, etc.) from 1.5T and 3T magnetic resonance (MR) scanners. AI4CMR uses artificial intelligence to automatically segment and quantify the different cardiac measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making. The user incorporating AI4CMR into their DICOM application of choice is responsible for implementing a user interface. AI4CMR also supports clinical diagnostics by calculating flow measurements of vascular structures in 2D phase-encoded cardiac MR images.

Source page: https://510kreport.com/device/K252084
Methodology: https://510kreport.com/methodology