Fluoroview Series Fluoroscopic Tables
by U.S. Imaging Tables, Inc. 510(k)
Active
510(k) K965096
Overview
The Fluoroview Series Fluoroscopic Tables are radiographic, tilting tables classified as Class 2 radiology devices. These tables are designed to support a patient and facilitate diagnostic procedures employing imaging techniques or to position a patient for various treatments in clinics or hospitals.
This device is authorized under FDA 510(k) clearance K965096. It is intended for use in clinical settings such as hospitals and clinics.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK965096 | Date27 Jan 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IXR
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1980
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from U.S. Imaging Tables, Inc.
Questions
What is the primary purpose of the Fluoroview Series tables?
These tables are designed to support patients and facilitate diagnostic procedures that utilize imaging techniques. They also serve to position patients appropriately for various treatments within hospital or clinical environments.
How are these tables classified for regulatory purposes?
The Fluoroview Series is classified as a Class 2 radiology device. This classification is based on the device's intended use as a radiographic, tilting table, which falls under regulation number 892.1980.
Is this device authorized for use in the United States?
Yes, the Fluoroview Series Fluoroscopic Tables are authorized under FDA 510(k) clearance K965096. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices.