ZIKON 100 DIGITAL X-RAY SYSTEM
Device Facts
| Record ID | K813032 |
|---|---|
| Device Name | ZIKON 100 DIGITAL X-RAY SYSTEM |
| Applicant | Kontron Instruments, Inc. |
| Product Code | JAB · Radiology |
| Decision Date | Nov 24, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1660 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A non-image-intensified fluoroscopic x-ray system is a device intended to be used to visualize anatomical structures by using a fluorescent screen to convert a pattern of x-radiation into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
