The following data is part of a premarket notification filed by Gendex Corp. with the FDA for Tbx Medical X-ray Table.
| Device ID | K854459 |
| 510k Number | K854459 |
| Device Name: | TBX MEDICAL X-RAY TABLE |
| Classification | Grid, Radiographic |
| 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 | IXJ |
| CFR Regulation Number | 892.1910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-06 |
| Decision Date | 1986-02-12 |