The following data is part of a premarket notification filed by Control-x, Inc. with the FDA for Milestone Ms 325 Radiographic X-ray Generator.
| Device ID | K913577 |
| 510k Number | K913577 |
| Device Name: | MILESTONE MS 325 RADIOGRAPHIC X-RAY GENERATOR |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | CONTROL-X, INC. 2289 WESTBROOKE DR. Columbus, OH 43228 |
| Contact | Zsigmond Kovacs |
| Correspondent | Zsigmond Kovacs CONTROL-X, INC. 2289 WESTBROOKE DR. Columbus, OH 43228 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-12 |
| Decision Date | 1991-11-05 |