The following data is part of a premarket notification filed by Gendex Corp. with the FDA for Atc725, Atc525, And Ap300.
| Device ID | K922165 |
| 510k Number | K922165 |
| Device Name: | ATC725, ATC525, AND AP300 |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | GENDEX CORP. 901 WEST OAKTON ST. Des Plaines, IL 60018 |
| Contact | Gerald V Levy |
| Correspondent | Gerald V Levy GENDEX CORP. 901 WEST OAKTON ST. Des Plaines, IL 60018 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-08 |
| Decision Date | 1992-07-27 |