REGULATORY APPROVALS

The Segment CMR and Segment CT software packages with optional additional module Strain analysis module and 3D segmentation module are CE-marked.

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

Quality assurance

ISO 13485 Certificate

93/42/ECC Certificate

CE mark

Medviso CE Product list

Segment CMR Decision

Segment CT Decision

FDA 510(k) approval

Segment CMR and Strain analysis module approval

Segment FDA approval