REGULATORY APPROVALS

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

 

The software packages Segment CMR, Segment CT, and Segment 3DPrint,  are CE-marked under the Medical Device Directive 93/42/EEC.

The Segment software package has FDA 510(k) clearance with number K090833, and the Segment CMR software package has FDA 510(k) clearance with number K163076. 

The Strain analysis module, is included in the CE mark, as well as in the FDA 510(k) clearance as part of the Segment CMR software package.

Segment CMR is registered with the Regulatory Authority in India.

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