Regulatory Information

Materialise Mimics Enlight is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file.

It is also intended as a software to aid in reading and interpreting DICOM compliant images for structural heart and vascular treatment options. For this purpose, Mimics Enlight provides additional visualization and measurement tools to enable the user to screen and plan the procedure.

The Mimics Enlight output file can be used for the fabrication of physical replicas of the output file using traditional or additive manufacturing methods. The physical replica can be used for diagnostic purposes in the field of cardiovascular applications.

Mimics Enlight should be used in conjunction with other diagnostic tools and expert clinical judgement.

Mimics Enlight is not intended to predict the performance of a medical device. Materialise Mimics Enlight is not intended for mammography imaging or diagnosis.

Materialise Mimics Enlight is a CE-marked product.
Materialise Mimics Enlight Research is not a medical device.

The below list of 3D printers has been validated for use with Mimics Enlight for the creation of diagnostics 3D models. Please refer to the Mimics Enlight user manual for additional instructions on good manufacturing practices for medical models. Other printers may be used with Mimics Enlight, however, these have not been validated by Materialise for the creation of diagnostic 3D printed models.