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 |
05404028000694 | K183105 | 000 |
05404028000663 | K183105 | 000 |
05404028000731 | K183105 | 000 |
05404028000724 | K183105 | 000 |
05404028000892 | K183105 | 000 |
05404028000885 | K183105 | 000 |
05404028000359 | K183105 | 000 |
05404028000335 | K183105 | 000 |
05404028000342 | K183105 | 000 |
05404028000366 | K183105 | 000 |
05404028000373 | K183105 | 000 |
E314MIMICSAAKNEECT0 | K183105 | 000 |
E314MIMICSAAHEARTCT0 | K183105 | 000 |
E314MIMICSAACMFCT0 | K183105 | 000 |
05420060346019 | K183105 | 000 |
05420060346002 | K183105 | 000 |
05404028000137 | K183105 | 000 |
05404028000120 | K183105 | 000 |
05404028000380 | K183105 | 000 |
05404028000090 | K183105 | 000 |