JAB · System, X-Ray, Fluoroscopic, Non-Image-Intensified
Radiology · 21 CFR 892.1660 · Class 2
Overview
| Product Code | JAB |
|---|---|
| Device Name | System, X-Ray, Fluoroscopic, Non-Image-Intensified |
| Regulation | 21 CFR 892.1660 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K970782 | IMAGING JET SYSTEM | General Robotic Devices, Inc. | Nov 13, 1997 | SESE |
| K813032 | ZIKON 100 DIGITAL X-RAY SYSTEM | Kontron Instruments, Inc. | Nov 24, 1981 | SESE |
Top Applicants
- General Robotic Devices, Inc. — 1 clearance
- Kontron Instruments, Inc. — 1 clearance
