Ultrasound devices use sound waves to create images of internal body parts or structures. The principle of using ultrasound for this purpose is based on the detection of differences in energy changes within an area that is being examined. These differences are picked up by an instrument called an ultrasound probe that uses radio waves to produce images of the tissue or structure.
In the U.S., manufacturers who submit 510(k) and receive marketing clearance are exempted from the Electronic Product Radiation Control (EPRC) reporting requirements in 21 CFR 1002.12, for diagnostic ultrasound devices. There are various applications where ultrasound is being used. One of them is the diagnosis of various abnormalities, diseases, and conditions. For instance, in the case of pregnancy, it can help in detecting abnormalities and potential problems in the early stages of pregnancy and can be used to monitor the baby inside the womb. Ultrasound devices are also helpful in monitoring and detecting pregnancies in the early stages. These devices can also help in detecting congenital abnormalities and problems. These devices can also be used to check the growth and development of the baby inside the mother's womb.
There are several types of diagnostic ultrasound devices available. MRI-guided focused ultrasound is one such noninvasive thermal ablation technology that uses magnetic resonance imaging (MRI) for target definition, treatment planning, and closed-loop control of energy deposition. The market is witnessing increasing launch of such devices. In December 2020, Royal Philips collaborated with InSightec to expand access to MR-guided focused ultrasound.
Ultrasound transducers are devices that detect or generate ultrasound vibration, which is a sound frequency of up to 100 GHz. They are used in many applications, such as ultrasound diagnosis, ultrasound examinations for internal disorders such as tumors, stress ulcers and acute injuries, and rehabilitation of the spine, brain, and extremities after accidents. They may also be used for monitoring blood pressure and pulse rate, temperature and skin temperatures.
There are two types of ultrasound transducers available for ultrasound applications: piezoelectric and dynamic. Piezoelectric ones generate their own power by utilizing the electrical charge of an electrically charged cell. The electricity passes through a material, such as a thin wafer, and converts the charge into photons. These can either be direct-transistor based, which has a charge sensitive detector, or opto-electronic based, which has a semiconductor detector. Dynamic transducers exhibit a different response than the former, which has a greater response time. They are available in both single and multiple-element configurations.
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