The following data is part of a premarket notification filed by Prexion Corporation with the FDA for Prexion 3d Excelsior.
| Device ID | K181983 |
| 510k Number | K181983 |
| Device Name: | PreXion 3D Excelsior |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | PreXion Corporation 1-14-1 Kandasuda-cho Chiyoda-ku, JP 101-0041 |
| Contact | Katsumi Hayashi |
| Correspondent | Katsumi Hayashi PreXion Corporation 1-14-1 Kandasuda-cho Chiyoda-ku, JP 101-0041 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-25 |
| Decision Date | 2018-08-17 |
| Summary: | summary |