The following data is part of a premarket notification filed by Radkor, Inc. with the FDA for Radkor, Xg-515.
| Device ID | K883081 |
| 510k Number | K883081 |
| Device Name: | RADKOR, XG-515 |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | RADKOR, INC. 16610 ASTON ST. Irvine, CA 92714 |
| Contact | Frank A Buzyn |
| Correspondent | Frank A Buzyn RADKOR, INC. 16610 ASTON ST. Irvine, CA 92714 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-21 |
| Decision Date | 1988-09-02 |