# K242062: 1CMR Pro

- Pathway: 510(k) (Abbreviated)
- Applicant: Mycardium AI Limited
- Decided: Nov 15, 2024 after 123 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: 9 generations back to K945512 (1995). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 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.
- K213998: cvi42 Auto Imaging Software Application, Circle Cardiovascular Imaging, Inc. (2022) Summary page 5.

## Indications for use
1CMR Pro is software that displays, analyses and transfers DICOM cardiovascular images acquired in Cardiovascular Magnetic Resonance (CMR) scanners, specifically structure, function and flow in the heart and major vessels using multi-slice, multi-phase, multi-parametric and velocity encoded CMR images. It is compatible with 1.5T and 3T CMR acquisitions. The intended patient population is both known healthy patients and patients in whom an underlying cardiac disease is suspected. The standard viewing tools are indicated for all patients. The AI analysis components are not intended for use in patients with a known congenital cardiac abnormality, children (Age<18), or individuals with pacemakers (even if MRI compatible).

Source page: https://510kreport.com/device/K242062
Methodology: https://510kreport.com/methodology