The following data is part of a premarket notification filed by Swissray Finatech, Inc. with the FDA for Gen-x 800/300.
| Device ID | K915339 |
| 510k Number | K915339 |
| Device Name: | GEN-X 800/300 |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | SWISSRAY FINATECH, INC. 7780 MALLARD DR. Mobile, AL 36695 |
| Contact | Michael Scott |
| Correspondent | Michael Scott SWISSRAY FINATECH, INC. 7780 MALLARD DR. Mobile, AL 36695 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-20 |
| Decision Date | 1992-01-09 |