Zikon 100 Digital X-Ray System
by Kontron Instruments, Inc. 510(k)
Active
510(k) K813032
Overview
The Zikon 100 Digital X-Ray System is a System, X-Ray, Fluoroscopic, Non-Image-Intensified device, designed to visualize anatomical structures using a fluorescent screen that converts x-radiation into a visible image. It may include signal analysis and display equipment, patient supports, and associated components. This fluoroscopic system enables real-time radiographic imaging for diagnostic and procedural guidance in radiology settings.
This device is supplied as a reusable medical system and is intended for use in radiology departments. It is classified as a Class II device under FDA regulations (Product Code JAB) and holds a FDA 510(k) clearance (K813032) for substantial equivalence. The system requires proper calibration, maintenance, and adherence to radiation safety protocols. No sterility or single-use specifications are indicated in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK813032 | Date24 Nov 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JAB
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1660
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Kontron Instruments, Inc.
Questions
What is the Zikon 100 Digital X-Ray System used for?
The Zikon 100 Digital X-Ray System is designed for real-time radiographic imaging in radiology settings. It uses a fluorescent screen to convert x-radiation into a visible image, enabling visualization of anatomical structures during diagnostic procedures or interventions. This includes fluoroscopic guidance for procedures requiring live imaging, such as orthopedic alignments, vascular studies, or other interventional radiology tasks.
Is the Zikon 100 Digital X-Ray System single-use or reusable?
The Zikon 100 Digital X-Ray System is supplied as a reusable medical device. Unlike single-use items, this system is intended for repeated use in radiology departments, provided it undergoes proper calibration, maintenance, and adherence to manufacturer guidelines. Reusability helps ensure cost-effectiveness and consistent performance over time.
Does the Zikon 100 Digital X-Ray System require sterility?
The regulatory data for the Zikon 100 Digital X-Ray System does not specify sterility requirements. Since it is a reusable fluoroscopic system, it is not intended to be sterile but must be cleaned, disinfected, and maintained according to standard radiology protocols to prevent contamination and ensure safe, repeated use.
What components are included in the Zikon 100 Digital X-Ray System?
The Zikon 100 Digital X-Ray System includes a fluorescent screen for image conversion, signal analysis and display equipment, patient supports, and associated components. These elements work together to provide real-time radiographic imaging, enabling clinicians to visualize anatomical structures during procedures. The system is designed as a comprehensive fluoroscopic unit for radiology departments.
What safety protocols must be followed when using the Zikon 100 Digital X-Ray System?
The Zikon 100 Digital X-Ray System requires adherence to radiation safety protocols to minimize exposure to patients and staff. Proper calibration and maintenance are essential to ensure accurate imaging and device functionality. Users must follow manufacturer instructions for safe operation, including positioning, shielding, and monitoring radiation dose levels during procedures.