ELECTROPHYSIOLOGY TILT TABLE MODEL #9660

K965105 · U.S. Imaging Tables, Inc. · IXR · Jan 30, 1997 · Radiology

Device Facts

• Record ID: K965105
• Device Name: ELECTROPHYSIOLOGY TILT TABLE MODEL #9660
• Applicant: U.S. Imaging Tables, Inc.
• Product Code: IXR · Radiology
• Decision Date: Jan 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1980
• Device Class: Class 2

Intended Use

This device, the Electrophysiology™ Tilt Table (Model 9660) and the Deluxe™ Arm Stretcher, Model 9660 are designed for clinical applications such as: to position patients for a diagnostic procedure employing some imaging technique or to position a patient for various treatments in clinics or hospitals. This device is used by a physician or a health care professional; this device is not operated by a patient.

Device Story

Electrophysiology™ Tilt Table (Model 9660) and Deluxe™ Arm Stretcher (Model 9660) provide mechanical support and adjustment to position patients for diagnostic imaging or clinical treatments. Operated by physicians or healthcare professionals in hospitals/clinics. Device facilitates patient access for imaging systems via adjustable arrangements. Design utilizes conventional materials and construction methods similar to existing imaging tables. Benefits include stable patient positioning to support diagnostic and therapeutic procedures.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Mobile fluoroscopic tilting table. Mechanical support and adjustment system. Conventional materials and construction consistent with industry standards for imaging tables. Class II device (21 CFR 892.11980).

Indications for Use

Indicated for patients requiring positioning for diagnostic imaging procedures or clinical treatments in hospital or clinic settings. Not for patient self-use.

Regulatory Classification

Identification

A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.

Predicate Devices

• Deluxe “C” Arm Stretcher, Model 056-004 (Biodex Medical Systems, Inc.)

Submission Summary (Full Text)

{0}

JAN 30 1997
19965105/A1
DUPLICATE

# EXHIBIT 15
## Summary of Safety & Effectiveness

This device, the *Electrophysiology™ Tilt Table* (Model 9660) and the *Deluxe™ Arm Stretcher*, Model 9660 are designed for clinical applications such as: to position patients for a diagnostic procedure employing some imaging technique or to position a patient for various treatments in clinics or hospitals. This device is used by a physician or a health care professional; this device is not operated by a patient. This is a Class II device. As such this device has a Classification name as: Mobile Fluoroscopic Tilting Table, as described in 21 CFR Part 892.11980. *U.S. Imaging Tables, Incorporated* has determined this device is substantially equivalent to a predicate medical device which is currently in commerce and is identified as: Deluxe “C” Arm Stretcher, Model 056-004, and is manufactured by Biodex Medical Systems, Inc. of Shirley New York.

A determination of substantial equivalence is based upon the following:

1. This device offers mechanical support and adjustment to suspend and position a patient into various arrangements where various parts of the patient would be accessible to an imaging system.
2. This device uses conventional design, construction and those materials commonly found in most similar Tables. This device uses conventional design, construction and those materials similar to the predicate, substantially equivalent device {except where this device is suited to a more general purpose design}.
3. This device has benefited from design, development, testing and production procedures that conform to Good Manufacturing Procedures.
4. This device has performance characteristics substantially equivalent to its predicate device {which includes differences to facilitate the various clinical applications for which it is intended}.
5. This device is safe and effective for the application for which it is intended and has been tested to confirm its safety and effectiveness.

U.S. Imaging Tables, Incorporated continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this device.

## CERTIFICATION:

I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device.

November 19, 1996
Date


Signed by
Mr. Ronald Denezzo
Acting Operations Manager
U.S. Imaging Tables, Incorporated
28 Central Avenue
Happauge, NY 11788
V-516 231 7300
F-516 231 7542

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