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Ultrasound Imaging
Description Ultrasound imaging (sonography) uses high-frequency sound waves to view soft tissues such as muscles and internal organs. Because ultrasound images are captured in real-time, they can show movement of the body's internal organs as well as blood flowing through blood vessels. In an ultrasound exam, a hand-held transducer is placed against the skin. The transducer sends out high frequency sound waves that reflect off of body structures. The returning sound waves, or echoes, are displayed as an image on a monitor. The image is based on the frequency and strength (amplitude) of the sound signal and the time it takes to return from the patient to the transducer. Unlike with an x-ray, there is no ionizing radiation exposure with this test. Ultrasound imaging is used in many types of examinations and procedures. Some examples include
Ultrasound imaging has been used for over 20 years and has an excellent safety record. It is non-ionizing radiation, so it does not have the same risks as x-rays or other types of ionizing radiation. Even though there are no known risks of ultrasound imaging, it can produce effects on the body. When ultrasound enters the body, it heats the tissues slightly. In some cases, it can also produce small pockets of gas in body fluids or tissues (cavitation). The long-term effects of tissue heating and cavitation are not known. Because of the particular concern for fetal exposures, national and international organizations have advocated prudent use of ultrasound imaging. Furthermore, the use of diagnostic ultrasound for non-medical purposes such as fetal keepsake videos has been discouraged.
Laws, Regulations & Performance Standards Manufacturers of electronic radiation emitting products sold in the United States are responsible for compliance with the Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product Radiation Control. Manufacturers of ultrasound imaging products are responsible for compliance with all applicable requirements of Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1000 through 1005:
There are no federal radiation safety performance standards for diagnostic ultrasound. Because they are medical devices, ultrasound imaging equipment must also comply with the medical device regulations. For more information, see Getting to Market with a Medical Device.
Updated March 26, 2008 |
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