REGULATORY APPROVALS

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.

Quality assurance

ISO 13485 Certificate

93/42/ECC Certificate

CE mark

Medviso CE Product list

Segment CMR Decision

Segment CT Decision

Segment 3DPrint Decision

FDA 510(k) approval

Segment CMR and Strain analysis module approval

Segment FDA approval