(38 days)
056-004
Not Found
No
The description focuses on the device's function as a patient support and positioning system for imaging and treatment, with no mention of AI, ML, or advanced image processing capabilities.
No
The intended use describes supporting and positioning patients for diagnostic procedures or treatments, not providing therapy itself.
No
The device is described as supporting patients and facilitating diagnostic procedures or positioning patients for treatment. It is a Mobile Fluoroscopic Tilting Table, which is equipment used during diagnostic imaging, not a diagnostic device itself.
No
The device description explicitly states it is a "Fluoroview "" Series Fluoroscopic Tables (Model 9680) and the Time Table C-Arm Stretcher. Model 9670," which are physical hardware devices used to support and position patients.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "support a patient and facilitate a diagnostic procedure employing some imaging technique or to position a patient for various treatments". This describes a device used on the patient's body for imaging or treatment positioning, not a device used to examine specimens from the body (which is the core of IVD).
- Device Description: The description reinforces this by stating it's a "Fluoroscopic Tables" and "C-Arm Stretcher" designed for "clinical applications such as: to support a patient and facilitate a diagnostic procedure employing some imaging technique or to position a patient for various treatments".
- Classification Name: The classification name is "Mobile Fluoroscopic Tilting Table", which clearly indicates its function related to imaging procedures performed on the patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the body (blood, urine, tissue, etc.), reagents, or any other typical components of an IVD.
Therefore, this device is a medical device used for patient positioning and support during imaging and treatment procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device, the Fluoroview "" Series Fluoroscopic Tables (Model 9680) and the Time Table C-Arm Stretcher. Model 9670 is designed for clinical applications such as: to support a patient and facilitate a diagnostic procedure employing some imaging technique or to position a patient for various treatments in clinics or hospitals.
Product codes
Not Found
Device Description
the Fluoroview "" Series Fluoroscopic Tables (Model 9680) and the Time Table C-Arm Stretcher. Model 9670 is designed for clinical applications such as: to support a patient and facilitate a diagnostic procedure employing some imaging technique or to position a patient for various treatments in clinics or hospitals.
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
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Key Metrics
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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 2 7 1997
EXHIBIT 15 Summary of Safety & Effectiveness
This device, the Fluoroview "" Series Fluoroscopic Tables (Model 9680) and the Time Table C-Arm Stretcher. Model 9670 is designed for clinical applications such as: to support a patient and facilitate 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 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:
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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.
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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}.
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This device has benefited from design, development, testing and production procedures that conform to Good Manufacturing Procedures.
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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}.
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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.
Date
Safety and Effectiveness applies for th
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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