The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Ct-modeller System.
| Device ID | K970617 |
| 510k Number | K970617 |
| Device Name: | CT-MODELLER SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | MATERIALISE N.V. 2922 SILVERDALE LN. Garland, TX 75044 |
| Contact | Lynn Stimpson |
| Correspondent | Lynn Stimpson MATERIALISE N.V. 2922 SILVERDALE LN. Garland, TX 75044 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-18 |
| Decision Date | 1997-04-21 |
| Summary: | summary |