(41 days)
056-004
Not Found
No
The description focuses on the mechanical function of a tilting table for patient positioning and does not mention any AI/ML capabilities.
No
The device is used to position patients for procedures, not to treat a medical condition.
No
The device description indicates its use is to position patients for procedures or treatments, not to diagnose conditions. Its classification as a "Mobile Fluoroscopic Tilting Table" further supports its role as a positioning device.
No
The device description explicitly identifies the device as a "Tilt Table" (Model 9660 and Delux Model 9660), which is a physical piece of equipment used for positioning patients. It is classified as a "Mobile Fluoroscopic Tilting Table" under 21 CFR Part 892.11980, further confirming it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to "position patients for a dia procedure employing some imaging technique or to position a patient for various treatments in or hospitals." This describes a device used on a patient for positioning during medical procedures, not a device used to examine specimens from a patient outside the body.
- Device Description: The description reinforces its use for patient positioning during clinical applications.
- Classification Name: The classification name is "Mobile Fluoroscopic Tilting Table," which clearly indicates a device used in conjunction with imaging equipment for patient positioning.
- Predicate Device: The predicate device is a "Deluxe 'C' Arm Stretcher," another device used for patient positioning during imaging procedures.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on the physical positioning of the patient.
N/A
Intended Use / Indications for Use
This device, the Electrophysiology 40 Tilt Table (Model 9660) and the Delux Model 9660 are designed for clinical applications such as: to position patients for a dia procedure employing some imaging technique or to position a patient for various treatments in or hospitals.
Product codes
Not Found
Device Description
This device, the Electrophysiology 40 Tilt Table (Model 9660) and the Delux Model 9660 are designed for clinical applications such as: to position patients for a dia procedure employing some imaging technique or to position a patient for various treatments in 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
This device is used by a physician or a health care professional; this device is not operated by a patient.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Deluxe "C" Arm Stretcher, Model 056-004
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1980 Radiologic table.
(a)
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.(b)
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.
0
JAN 30 1997
EXHIBIT 15
K965105/A1
Summary of Safety & Effectiveness
This device, the Electrophysiology 40 Tilt Table (Model 9660) and the Delux Model 9660 are designed for clinical applications such as: to position patients for a dia procedure employing some imaging technique or to position a patient for various treatments in 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:
- This device offers mechanical support and adjustment to suspend and position a patient into various 1. arrangements where various parts of the patient would be accessible to an imaging system.
- This device uses conventional design, construction and those materials commonly found in 2. 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}.
- This device has benefited from design, development, testing and production procedures that conform to Good 3. Manufacturing Procedures.
- This device has performance characteristics substantially equivalent to its predicate device {which includes 4. differences to facilitate the various clinical applications for which it is intended }.
- This device is safe and effective for the application for which it is intended and has been tested to confirm its રું ર 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
Ronald Dahlke
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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