The following data is part of a premarket notification filed by Gendex Corp. with the FDA for Gx-c Cephalometer.
| Device ID | K920189 |
| 510k Number | K920189 |
| Device Name: | GX-C CEPHALOMETER |
| Classification | Cephalometer |
| Applicant | GENDEX CORP. 901 WEST OAKTON ST. Des Plaines, IL 60018 |
| Contact | Gerald Llevy |
| Correspondent | Gerald Llevy GENDEX CORP. 901 WEST OAKTON ST. Des Plaines, IL 60018 |
| Product Code | EAG |
| CFR Regulation Number | 872.1830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-15 |
| Decision Date | 1992-04-28 |