Regulatory Information
The Medical edition of the Materialise Mimics® Innovation Suite currently consists of the following software components: Materialise Mimics® Medical version 25.0 and Materialise 3-matic® Medical version 17.0 (released 2022). Mimics® Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. Mimics® Medical is also intended for measuring and treatment planning. The Mimics® Medical output 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 orthopedic, maxillofacial and cardiovascular applications. Mimics® Medical should be used in conjunction with expert clinical judgement. 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 Materialise Mimics® Innovation Suite currently consists of the following software components: Materialise Mimics® version 25.0 and Materialise 3-matic® version 17.0 (released 2022). Materialise Mimics and Materialise 3-matic are not medical devices.
Mimics® Medical and 3-matic® Medical are medical devices and CE-marked products.
The below list of 3D printers has been validated for use with Mimics Medical for the creation of diagnostics 3D models. Please refer to the Mimics Medical user manual for additional instructions on good manufacturing practices for medical models. Other printers may be used with Mimics Medical, however, these have not been validated by Materialise for the creation of diagnostic 3D printed models.
| Technology | Manufacturer | Model | Material | Applications |
|---|---|---|---|---|
| SLS | EOS | P730 | PA2201 | Orthopedic, Maxillofacial, Cardiovascular |
| Vat Polymerization | Formlabs | Form 2 | Clear FLGGPCL02 | Orthopedic, Maxillofacial, Cardiovascular |
| Vat Polymerization | Formlabs | Form 3/3B/3BL | Grey V4 FLGPGR04 Clear V4 FLGPGR04 White V4 FLGPWH04 |
Orthopedic, Maxillofacial, Cardiovascular |
| PolyJet | Stratasys | Connex2 500 | VeroWhite | Orthopedic, Maxillofacial, Cardiovascular |
| PolyJet | Stratasys | J5 MediJet | VeroVividTM Cyan, VeroVividTM Magenta, VeroVividTM Yellow, DraftWhite, MED610, MED615RGD, VeroUltraClearTMS, ElasticoTM Clear | Orthopedic, Maxillofacial, Cardiovascular |
| PolyJet | Stratasys | J750/J735 | Agilus, VeroBlackPlus, VeroClear, VeroCyan, VeroGrey, VeroMagenta, VeroPureWhite, VeroYellow | Orthopedic, Maxillofacial, Cardiovascular |
| PolyJet | Stratasys | Objet30 Prime | MED610 | Orthopedic, Maxillofacial, Cardiovascular |
| Material Extrusion | Ultimaker | 5S | PLA | Orthopedic, Maxillofacial, Cardiovascular |
| Multi Jet Fusion | HP | MJF 580 | HP 3D HR CB PA 12 | Orthopedic, Maxillofacial, Cardiovascular |
Materialise medical device software may not be available in all markets because product availability is subject to the regulatory and/ or medical practices in individual markets. In countries where no regulatory registration is obtained of Mimics and/or 3-matic Medical, a research version is available. Please contact your Materialise representative if you have questions about the availability of Materialise medical device software in your area.
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