Regulatory Information

The Medical edition of the Mimics® Innovation Suite currently consists of the following software components: Mimics® Medical version 19.0 and 3-matic® Medical version 11.0 (released 2016). Mimics® Medical is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging scanner. It is also used as pre-operative software for simulating /evaluating surgical treatment options. 3-matic® Medical is intended for use as software for computer assisted design and manufacturing of medical exo- and endo-prostheses, patient-specific medical and dental/orthodontic accessories and dental restorations.

The Research edition of the Mimics® Innovation Suite currently consists of the following software components: Mimics® Research version 19.0 and 3-matic® Research version 11.0 (released 2016). Mimics® Research is intended only for research purposes. It is intended as a software interface and image segmentation system for the transfer of imaging information from a variety of imaging sources to an output file. It is also used as software for simulating, measuring and modeling in the field of biomedical research. "Mimics® Research" must not be used, and is not intended to be used, for any medical purpose whatsoever. 3-matic® Research is intended for use as a software for computer assisted design and engineering in the field of biomedical research. "3-matic® Research" must not be used, and is not intended to be used, for the design or manufacturing of medical devices of any kind.

Mimics® Medical and 3-matic® Medical are CE-marked products.