Ultromics Ltd radiology AI products

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Which exact product, version and licensed modules are in the current offer?
Do related FDA submissions document the same scope, or different functions and versions?
Which costs, support obligations and local acceptance tests remain unresolved?

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Radiology AI pricing and total cost of ownership

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FDA-cleared K201555

EchoGo Pro

Ultromics Ltd

Authorized purpose: Adjunct to diagnostic stress echocardiography for patients undergoing assessment for coronary artery disease; an interpreting physician uses the output as information that may assist diagnosis, not as the sole basis for management.

Modality: Ultrasound
Anatomy: Heart, especially the left ventricle and stress-echocardiographic A2C, A4C, and mid-ventricular SAX views.
Decision: 2020-12-18

Cardiac imaging Ultrasound workflow

FDA-cleared K191171

EchoGo Core

Ultromics Ltd

Authorized purpose: EchoGo Core automatically measures ejection fraction, global longitudinal strain, and left-ventricular volume from echocardiograms and reports the measurements to a clinician within the labeled workflow.

Modality: Ultrasound
Anatomy: Heart/Cardiovascular
Decision: 2019-11-13

Cardiac imaging Quantification and segmentation Ultrasound workflow