The following data is part of a premarket notification filed by Gendex Corp. with the FDA for Gx-mobile X-ray Unit.
| Device ID | K873982 |
| 510k Number | K873982 |
| Device Name: | GX-MOBILE X-RAY UNIT |
| Classification | System, X-ray, Mobile |
| 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 | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-30 |
| Decision Date | 1987-10-30 |