The following data is part of a premarket notification filed by Materialise Nv with the FDA for Mimics Medical.
| Device ID | K183105 |
| 510k Number | K183105 |
| Device Name: | Mimics Medical |
| Classification | System, Image Processing, Radiological |
| Applicant | Materialise NV Technologielaan 15 Leuven, BE 3001 |
| Contact | Carina Martins |
| Correspondent | Mieke Janssen Materialise NV Technologielaan 15 Leuven, BE 3001 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-08 |
| Decision Date | 2019-03-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E314MIMICSAAKNEEMRI0 | K183105 | 000 |
| 05404028000731 | K183105 | 000 |
| 05404028000663 | K183105 | 000 |
| 05404028000694 | K183105 | 000 |
| 05404028000342 | K183105 | 000 |
| 05404028000366 | K183105 | 000 |
| 05404028000373 | K183105 | 000 |
| 05404028000380 | K183105 | 000 |
| 05404028000120 | K183105 | 000 |
| 05404028000137 | K183105 | 000 |
| 05420060346002 | K183105 | 000 |
| 05420060346019 | K183105 | 000 |
| E314MIMICSAACMFCT0 | K183105 | 000 |
| E314MIMICSAAHEARTCT0 | K183105 | 000 |
| E314MIMICSAAKNEECT0 | K183105 | 000 |
| 05404028000724 | K183105 | 000 |