The following data is part of a premarket notification filed by Summit Industries, Inc. with the FDA for Xma 325 (x-ray Generator).
| Device ID | K850117 |
| 510k Number | K850117 |
| Device Name: | XMA 325 (X-RAY GENERATOR) |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | SUMMIT INDUSTRIES, INC. 2901 WEST LAWRENCE AVE. Chicago, IL 60625 |
| Contact | Jim K Walsh |
| Correspondent | Jim K Walsh SUMMIT INDUSTRIES, INC. 2901 WEST LAWRENCE AVE. Chicago, IL 60625 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-14 |
| Decision Date | 1985-04-09 |