The following data is part of a premarket notification filed by Gendex Corp. with the FDA for Gx-pan Panoramic Dental X-ray System.
| Device ID | K952598 |
| 510k Number | K952598 |
| Device Name: | GX-PAN PANORAMIC DENTAL X-RAY SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | GENDEX CORP. 901 WEST OAKTON ST. Des Plaines, IL 60018 |
| Contact | Alan P Krema |
| Correspondent | Alan P Krema GENDEX CORP. 901 WEST OAKTON ST. Des Plaines, IL 60018 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-06 |
| Decision Date | 1995-06-29 |