Mycardium AI Limited radiology AI products

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Radiology AI pricing and total cost of ownership

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FDA-cleared K250670

EchoConfidence (USA)

Mycardium AI Limited

Authorized purpose: Transthoracic echocardiography view classification, cardiac structure segmentation, functional measurements and Doppler review and report support.

Modality: Ultrasound
Anatomy: Heart/Cardiovascular
Decision: 2025-06-30

FDA-cleared K242062

Authorized purpose: 1CMR Pro displays, analyzes, and transfers DICOM cardiovascular images acquired in CMR scanners, including multi-slice, multi-phase, multi-parametric, and velocity-encoded CMR images of the heart and major vessels. The FDA material describes use with 1.5T and 3T CMR scanners and support for healthy subjects and patients with suspected cardiac disease.

Modality: MRI
Anatomy: Heart/cardiovascular structures and major vessels
Decision: 2024-11-15

Cardiac imaging