The following data is part of a premarket notification filed by Materialise Nv with the FDA for Mimics Inprint.
Device ID | K173619 |
510k Number | K173619 |
Device Name: | Mimics InPrint |
Classification | System, Image Processing, Radiological |
Applicant | Materialise NV Technologielaan 15 Leuven, BE 3001 |
Contact | Oliver Clemens |
Correspondent | Oliver Clemens 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 | 2017-11-22 |
Decision Date | 2018-03-21 |
Summary: | summary |