The following data is part of a premarket notification filed by Radkor, Inc. with the FDA for Radkor Dxg-650r.
| Device ID | K895969 |
| 510k Number | K895969 |
| Device Name: | RADKOR DXG-650R |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | RADKOR, INC. 16610 ASTON ST. Irvine, CA 92714 |
| Contact | Jack E Briggs |
| Correspondent | Jack E Briggs 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 | 1989-10-12 |
| Decision Date | 1989-11-13 |