The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Materialise Mimics Enlight.
| Device ID | K190874 |
| 510k Number | K190874 |
| Device Name: | Materialise Mimics Enlight |
| Classification | System, Image Processing, Radiological |
| Applicant | Materialise N.V. Technologielaan 15 Leuven, BE 3001 |
| Contact | Mieke Janssen |
| Correspondent | Mieke Janssen Materialise N.V. 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 | 2019-04-04 |
| Decision Date | 2019-06-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E314MIMICSENLIGHTMED0 | K190874 | 000 |