The following data is part of a premarket notification filed by Xerox Medical Systems with the FDA for Xerox 120 Sys Mammographic X-ray.
| Device ID | K832733 |
| 510k Number | K832733 |
| Device Name: | XEROX 120 SYS MAMMOGRAPHIC X-RAY |
| Classification | System, X-ray, Mammographic |
| Applicant | XEROX MEDICAL SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-19 |
| Decision Date | 1983-09-29 |