FDA INDICATIONS

Spectron IR Medical Infrared Imaging System

FDA 510(k) Indications for Use

FDA 510(k) #KO32471

Indications for use: The Spectron IR Clinical Infrared Imaging System is intended for adjunctive diagnostic screening for the detection of breast cancer and other uses such as: peripheral vascular disease, neuromusculoskeletal disorders, extracranial cerebral and facial vascular disease, thyroid gland abnormalities, and various other neoplastic, metabolic and inflammatory conditions.

Medical Thermography Technology FAQs

What is a micro-bolometer detector?

A micro-bolometer is a specific type of resistor that is used as an infrared detector in a thermal camera. There are three types currently being used to make infrared detectors: Amorphous Silicon, Barium Strontium Titanate, and Vanadium Oxide. Spectron IR cameras use the most sensitive detectors in order to provide the best image possible. Spectron IR cameras use vanadium oxide exclusively in all our high resolution 640×480 cameras.

What does it mean when I see a camera that has numbers like 320×240?

This number refers to the number of individual infrared sensors (pixels) that will be used to produce the image (ex. 320×240 = 76,800 sensors). The infrared sensors are arranged on an array with 320 sensors vertically and 240 sensors horizontally. This is also known as the absolute resolution. Just like when you purchase a digital camera, you get to chose the number of megapixels that will sense the incoming light (1 megapixel = 1000×1000 = 1 million light detectors). In the simplest terms, the more infrared sensors you have the more detailed the image, as long as all other specifications of the hardware are of high quality.

What is Spatial Resolution?

Spatial resolution refers to the ability of a camera to detect fine detail. When two different areas of heat are brought close together, the spatial resolution will determine whether or not you will be able to see the two objects as completely distinct areas. Spatial resolution is very important when you need to see fine detail such as blood vessels.

How important is the thermal imaging sensitivity of my camera?

This is extremely important; you will see this technical aspect written in the specifications as the NEDT (Noise Equivalent Temperature Difference). Thermal sensitivity is necessary in order to detect minute temperature differences. An infrared camera that is capable of detecting extremely small temperature differences will detect more in all circumstances. When looking at this specification what you want is a low NEDT number.

Another important aspect is “noise”. If a camera has too much “noise” the image will not be clear, but rather appear as if you are looking through a screen door. If enough “noise” is present you may also see lines, jagged edges, and pixilated images.

When evaluating an infrared imaging camera, as long as the rest of the specifications are exceptional (ex. absolute and spatial resolution, lens type, detector type, etc.), the lower the NEDT number the better the image quality.

Is the lens of an infrared camera just as important as a regular camera?

Absolutely!
The Spectron IR camera uses a large 50 mm lens.· In simplest terms, a larger lens allows for more light or infrared radiation to pass through it. As such more infrared will reach the detector, which means that the detector will react more to this incoming radiation. When making a comparison of cameras with the same detector, the camera with the larger diameter lens will have better NEDT values. Spectron systems use the largest lens that is practical for our detectors providing you with the highest image quality.

Why is Frame Rate important?

Frame rate refers to the ability of the camera to image objects in motion. When a camera processes images at a fast frame rate, objects can be viewed moving freely on the screen without blurring. This is also referred to as “live” or “real-time” imaging. This aspect of infrared imaging is very important as an image cannot be focused properly without real-time capability. An infrared image that is not properly focused is useless. Detail is lost and accurate temperature data is severely compromised. Some imaging systems are not able to perform focusing of a live image. This is unacceptable in a modern infrared imaging system. All Spectron IR 640×480 systems have real-time high frame rate capture capability.