The following data is part of a premarket notification filed by Gendex Corp. with the FDA for Gx-2000 Stationary X-ray Generator.
| Device ID | K890083 |
| 510k Number | K890083 |
| Device Name: | GX-2000 STATIONARY X-RAY GENERATOR |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | GENDEX CORP. 11341 W. MELROSE ST. Franklin Park, IL 60131 |
| Contact | Gerald V Levy |
| Correspondent | Gerald V Levy GENDEX CORP. 11341 W. MELROSE ST. Franklin Park, IL 60131 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-10 |
| Decision Date | 1989-03-31 |