Regulatory approvals

Regulatory approvals

The Segment CMR and Segment CT software packages are CE-marked.
The Segment CMR software and the Strain module is FDA 510(k) approved with 510(k) number K163076 and the Segment software is FDA 510(k) approved with 510(k) number K090833.

Quality assurance

ISO 13485 Certificate

93/42/ECC Certificate

CE mark

 Medviso CE Product list

Segment CMR Technical File Decision

Segment CT Product Decision

FDA approval

 Segment CMR and Strain module FDA approval

 Segment FDA approval