# K220624: AI4CMR v1.0

- Pathway: 510(k) (Traditional)
- Applicant: Ai4medimaging Medical Solutions S.A.
- Decided: Jul 22, 2022 after 141 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 8 generations back to K945512 (1995). 17 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203256: Imbio RV/LV Software, Imbio, LLC (2021) Summary page 4.

## Most influential descendants
- K252084: AI4CMR v2.0 (2026), 0 descendants of its own
- K242062: 1CMR Pro (2024), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K220624
Methodology: https://510kreport.com/methodology