The following data is part of a premarket notification filed by Control-x, Inc. with the FDA for Pcx 1050hf Radiographic X-ray Generator.
| Device ID | K920349 |
| 510k Number | K920349 |
| Device Name: | PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | CONTROL-X, INC. 2289 WESTBROOKE DR. Columbus, OH 43228 |
| Contact | Laszlo Adrovitz |
| Correspondent | Laszlo Adrovitz 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 | 1992-01-24 |
| Decision Date | 1993-02-12 |