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Medical X-Rays
DescriptionX-rays refer to radiation, waves or particles that travel through the air like light or radio signals. X-ray energy is high enough that some radiation passes through objects (such as internal organs, body tissues, and clothing) and onto x-ray detectors (such as film or a detector linked to a computer monitor). In general, objects that are more dense (such as bones and calcium deposits) absorb more of the radiation from the x-rays and don’t allow as much to pass through them. These objects leave a different image on the detector than less dense objects. Specially trained or experienced physicians can read these images to diagnose medical conditions or injuries. ProceduresMedical x-rays are used in many types of examinations and procedures. Some examples include
Risks/BenefitsMedical x-rays have increased the ability to detect disease or injury early enough for a medical problem to be managed, treated, or cured. When applied and performed appropriately, these procedures can improve health and may even save a person’s life. X-ray energy also has a small potential to harm living tissue. The most significant risks are:
The risk of developing cancer from radiation exposure is generally small, and it depends on at least three factors—the amount of radiation dose, the age at exposure, and the sex of the person exposed:
Information for PatientsYou can reduce your radiation risks and contribute to your successful examination or procedure by:
See also: RadiologyInfo: The Radiology Information Resource for Patients. Information for Professionals
Laws, Regulations & StandardsManufacturers 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 medical x-ray products are responsible for compliance with all applicable requirements of Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1000 through 1005: 1003 - Notification of defects or failure to comply 1004 - Repurchase, repairs, or replacement of electronic products 1005 - Importation of electronic products In addition, medical x-ray products must comply with radiation safety performance standards in Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1010 and 1020. 1010 - Performance standards for electronic products: general 1020.30 - Diagnostic x-ray systems and their major components 1020.31 - Radiographic equipment 1020.32 - Fluoroscopic equipment 1020.33 - Computed tomography (CT) equipment Because they are medical devices, medical x-ray equipment must also comply with the medical device regulations. For more information, see Getting to Market with a Medical Device. Industry Guidance
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Updated January 6, 2009 |
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Center for Devices and Radiological Health / CDRH