Search Results

to position patients for a dia procedure employing some imaging technique or to position a patient for various treatments in or hospitals.

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.

The provided text is a Summary of Safety & Effectiveness for a medical device, the Electrophysiology 40 Tilt Table (Model 9660). It is a premarket notification (510(k)) submission from 1997, which focuses on demonstrating substantial equivalence to a predicate device.

Unfortunately, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The summary states:

• "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 }."
• "This device is safe and effective for the application for which it is intended and has been tested to confirm its safety and effectiveness."

However, it does not provide any specific data, metrics, or details about these tests, nor does it define any acceptance criteria. It also doesn't involve any AI or algorithm performance.

Therefore, I cannot populate the table or answer the specific questions because the necessary information is not present in the provided text.

Ask a specific question about this device

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, 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.

This document is a 510(k) summary for a Class II medical device, specifically fluoroscopic tables and a C-arm stretcher designed for patient positioning during diagnostic imaging or treatment. It aims to demonstrate substantial equivalence to a predicate device.

Based on the provided text, it's explicitly stated that the device's substantial equivalence is based on its mechanical support, conventional design and materials, adherence to Good Manufacturing Procedures, performance characteristics, and safety and effectiveness for its intended application.

However, the provided text does not contain any information regarding specific acceptance criteria, study methodologies, sample sizes, expert qualifications, ground truth establishment, or any of the detailed metrics typically associated with proving a device meets acceptance criteria through a formal study.

The document primarily focuses on establishing substantial equivalence to a predicate device by asserting:

• The device offers mechanical support and adjustment.
• It uses conventional design, construction, and materials.
• It conforms to Good Manufacturing Procedures.
• It has performance characteristics substantially equivalent to its predicate.
• It is safe and effective for its intended use.

Therefore, I cannot populate the requested table or sections because the necessary detailed information is not present in the provided text. The document describes the basis for regulatory clearance (substantial equivalence), but not a rigorous study proving specific performance metrics against pre-defined acceptance criteria.

Missing Information:

• Specific quantitative acceptance criteria are not mentioned. The document states "performance characteristics substantially equivalent to its predicate device," but doesn't define what those characteristics are or what thresholds must be met.
• No study details are provided. There's no mention of a particular study, its design, endpoints, or results. The statement "This device has been tested to confirm its safety and effectiveness" is a general claim, not a description of a specific study.
• Sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, or training set information are entirely absent.

Ask a specific question about this device