The following data is part of a premarket notification filed by Xerox Medical Systems with the FDA for Xeroradiography Liquid Toner Imaging System.
| Device ID | K853459 |
| 510k Number | K853459 |
| Device Name: | XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM |
| Classification | System, Imaging, X-ray, Electrostatic |
| Applicant | XEROX MEDICAL SYSTEMS P.O. BOX 5786 125 NORTH VENEDO AVENUE Pasadena, CA 91107 |
| Contact | Ellen M Proctor |
| Correspondent | Ellen M Proctor XEROX MEDICAL SYSTEMS P.O. BOX 5786 125 NORTH VENEDO AVENUE Pasadena, CA 91107 |
| Product Code | IXK |
| CFR Regulation Number | 892.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-16 |
| Decision Date | 1985-10-30 |