REGULATORY APPROVALS

Our software solutions are of highest quality and are CE-marked and have FDA clearance

The Segment CMR, Segment 3DPrint, Segment CT software packages with optional additional module Strain analysis module are CE-marked.

The Segment CMR software package with optional additional module Strain analysis module has FDA 510(k) clearance with number K163076. The Segment software package has FDA 510(k) clearance with number K090833. 

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