The following data is part of a premarket notification filed by Materialise Nv with the FDA for Surgicase Viewer.
| Device ID | K170419 |
| 510k Number | K170419 |
| Device Name: | SurgiCase Viewer |
| 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 | 2017-02-13 |
| Decision Date | 2017-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E314SURGICASEVIEWER0 | K170419 | 000 |