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The IRIS-3 Infrared Imaging System is a thermal camera based imaging device intended for use during coronary bypass surgery. Thermal imaging of the exposed heart, using the IRIS-3, permits the viewing and recording of changes in tissue temperature prior to grafting, cooling of the myocardial, and perfusion of the tissue distal to the anastomosis after grafting. Recording of the temperature difference may be obtained using the videocassette recorder.

The IRIS-3 Infrared Imaging System is a thermal camera based imaging device.

I am sorry, but the provided text is a 510(k) clearance letter and an "Indications For Use" statement from the FDA for a device called the "Thermatrek Iris-3 Infrared Imaging System."

This document does not contain any information regarding:

• Acceptance criteria for the device's performance.
• Details of any study that proves the device meets acceptance criteria.
• Sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for any studies.

The document primarily states that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976, and outlines its intended use during coronary bypass surgery for thermal imaging.

Therefore, I cannot provide the requested information based on the input text.

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