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X-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.
Medical x-rays are used in many types of examinations and procedures. Some examples include
- x-ray radiography (to find orthopedic damage, tumors, pneumonias, foreign objects, etc);
- mammography (to image the internal structures of breasts)
- CT (computed tomography) (to produce cross-sectional images of the body)
- fluoroscopy (to dynamically visualize the body for example to see where to remove plaque from coronary arteries or where to place stents to keep those arteries open)
- radiation therapy in cancer treatment
Medical 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:
- a small increase in the possibility that a person exposed to x-rays will develop cancer later in life; and
- cataracts and skin burns only at very high levels of radiation exposure and in only very few procedures.
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:
- The lifetime risk of cancer increases the larger the dose and the more x-ray exams a patient undergoes.
- The lifetime risk of cancer is larger for a patient who received x-rays at a younger age than for one who receives them at an older age.
- Women are at a somewhat higher lifetime risk than men for developing radiation-associated cancer after receiving the same exposures at the same ages.
You can reduce your radiation risks and contribute to your successful examination or procedure by:
- Keeping a “medical x-ray history” with the names of your radiological exams or procedures, the dates and places where you had them, and the physicians who referred you for those exams;
- Making your current healthcare providers aware of your medical x-ray history;
- Asking your healthcare provider about whether or not alternatives to x-ray exams would allow the provider to make a good assessment or provide appropriate treatment for your medical situation;
- Providing interpreting physicians and referring physicians with recent x-ray images and radiology reports; and
- Informing radiologists or x-ray technologists in advance if you are pregnant or think you may be pregnant.
- Alliance for Radiation Safety in Pediatric Imaging image gently Campaign
- American College of Radiology Appropriateness Criteria
- Radiation Injuries with Fluoroscopy
- Questions and Answers for Physicians about Medical X-Rays
- Questions and Answers about the Radiation Safety Performance Standard for Diagnostic X-Ray Systems (June 10, 2005)
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 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:
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.
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.
Required Reports for the Medical X-Ray Manufacturers or Industry
Diagnostic X-ray Reports of Assembly A Guide for Submission of an Abbreviated Radiation Safety Reports on Cephalometric Devices Intended for Diagnostic Use(PDF - 372KB) Guide for Filling Annual Reports for X-Ray Components and Systems(PDF - 599KB) A Guide for the Submission of Initial Reports on Diagnostic X-ray Systems and Their Major Components(PDF - 843KB) Diagnostic X-Ray CT Products Radiation Safety Report(PDF - 568KB) FDA eSubmitter
Industry Guidance - Documents of Interest
Guidance for Industry and Food and Drug Administration Staff - Assembler's Guide to Diagnostic X-Ray Equipment Inspection of Domestic and Foreign Manufacturers of Diagnostic X-Ray Equipment Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography FDA Issues Amendments to the Federal Radiation Safety Performance Standard for Diagnostic X-Ray Systems Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems Routine Compliance Testing Procedures for Diagnostic X-Ray Systems Resource Manual for Compliance Test Parameters of Diagnostic X-Ray Systems Guidance for Industry and FDA Staff - Addition of URLs to Electronic Product Labeling
Does the Product Emit Radiation? Getting a Radiation Emitting Product to Market Records and Reporting (Radiation-Emitting Products) Importing and Exporting Electronic Products Compliance Program Guidance Manual CP 7386.003 Field Compliance Testing of Diagnostic (Medical) X-ray Equipment - Guidance for FDA Staff CDRH Organ Dose Handbooks ADA / FDA Guide to Patient Selection for Dental Radiographs Information for Industry: X-ray Imaging Devices