The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Zikon 100 Digital X-ray System.
| Device ID | K813032 |
| 510k Number | K813032 |
| Device Name: | ZIKON 100 DIGITAL X-RAY SYSTEM |
| Classification | System, X-ray, Fluoroscopic, Non-image-intensified |
| Applicant | KONTRON INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JAB |
| CFR Regulation Number | 892.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-28 |
| Decision Date | 1981-11-24 |