The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Surgicase Orthognathic Software Wizard.
| Device ID | K111641 |
| 510k Number | K111641 |
| Device Name: | SURGICASE ORTHOGNATHIC SOFTWARE WIZARD |
| Classification | System, Image Processing, Radiological |
| Applicant | MATERIALISE N.V. TECHNOLOGIELAAN 15 Leuven, BE 3001 |
| Contact | Oliver Clemens |
| Correspondent | Oliver Clemens 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 | 2011-06-13 |
| Decision Date | 2011-09-26 |
| Summary: | summary |