The following data is part of a premarket notification filed by Gendex Corp. with the FDA for Gx Ceph.
| Device ID | K842463 |
| 510k Number | K842463 |
| Device Name: | GX CEPH |
| Classification | Cephalometer |
| Applicant | GENDEX CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EAG |
| CFR Regulation Number | 872.1830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-22 |
| Decision Date | 1984-08-02 |