Electrophysiology Tilt Table Model 9660
by U.S. Imaging Tables, Inc. 510(k)
Active
510(k) K965105
Overview
The Electrophysiology Tilt Table Model 9660 is a radiographic, tilting table designed for patient positioning during diagnostic imaging and clinical electrophysiology procedures. It provides adjustable mechanical support to facilitate optimal access for imaging systems while maintaining patient stability during diagnostic evaluations.
This device is intended for use in radiology settings and is supplied as a reusable medical table. It has received FDA 510(k) clearance under the K-number K965105, classified as a Class II device. The table is engineered for adjustable positioning and is operated by healthcare professionals in hospital or clinic environments.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK965105 | Date30 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- Withdrawn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 types of medical procedures is this tilt table primarily designed for, and where would it typically be used in a clinical setting?
This Electrophysiology Tilt Table Model #9660 is specifically designed for patient positioning during diagnostic imaging and electrophysiology procedures. It provides adjustable mechanical support to ensure optimal access for imaging systems while keeping the patient stable. It is intended for use in radiology settings, such as hospitals or clinics, where radiographic imaging and electrophysiology evaluations are conducted.
Is this tilt table reusable, and if so, what does that mean for maintenance and cleaning protocols?
Yes, this tilt table is supplied as a reusable medical device. As a reusable table, it must be cleaned and maintained according to established infection control protocols to ensure patient safety and device longevity. Healthcare facilities will need to follow manufacturer guidelines for disinfection, sterilization (if applicable), and regular maintenance to prevent wear and tear.
How do I determine the correct size or model for my facility’s needs, given the specifications provided?
The specifications provided do not list specific size variations for the Model #9660, but it is classified as a radiographic, tilting table designed for adjustable positioning. To determine the correct fit for your facility, you should consult the manufacturer’s documentation or contact U.S. Imaging Tables, Inc. directly. They can provide details on weight capacity, table dimensions, and compatibility with your existing imaging systems to ensure optimal use.
What regulatory pathway was followed for this device’s approval, and how does that affect its use in clinical practice?
This device received FDA 510(k) clearance under the K-number K965105, classified as a Class II device. The clearance was granted through a traditional review process by the Radiology (RA) Advisory Committee, with a decision of Substantially Equivalent (SESE). This means the device meets FDA standards for safety and effectiveness as determined by its equivalence to a predicate device already on the market. Clinically, this ensures the device adheres to regulatory requirements for use in radiology settings.