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                Medical X-ray Imaging

Medical X-ray Imaging

                        Radiography
          Computed Tomography (CT)
          Dental Cone-beam Computed Tomography
          Fluoroscopy
          Mammography Home
          Radiation-Emitting Products
          Radiation-Emitting Products and Procedures
          Medical Imaging
          Medical X-ray Imaging
          RadiographyMedical X-ray Imaging Radiography
  
  	
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Description
	Uses
	Risks/Benefits
	Information for Patients
	Information for Professionals
	Laws, Regulations & Performance Standards
	Industry Guidance
	Other ResourcesDescription

Medical radiography is a broad term that covers several types of studies that require the visualization of the internal parts of the body using x-ray techniques. For the purposes of this page radiography means a technique for generating and recording an x-ray pattern for the purpose of providing the user with a static image(s) after termination of the exposure. It is differentiated from *fluoroscopy*,*mammography*, and *computed tomography* which are discussed elsewhere. Radiography may also be used during the planning of radiation therapy treatment. (links are to the pages in this section)

It is used to diagnose or treat patients by recording images of the internal structure of the body to assess the presence or absence of disease, foreign objects, and structural damage or anomaly.

During a radiographic procedure, an x-ray beam is passed through the body. A portion of the x-rays are absorbed or scattered by the internal structure and the remaining x-ray pattern is transmitted to a detector so that an image may be recorded for later evaluation. The recoding of the pattern may occur on film or through electronic means.

Uses

Radiography is used in many types of examinations and procedures where a record of a static image is desired. Some examples include

Dental examination
	Verification of correct placement of surgical markers prior to invasive procedures
	Mammography
	Orthopedic evaluations
	Spot film or static recording during fluoroscopy
	Chiropractic examinationsRisks/Benefits

Radiography is a type of x-ray procedure, and it carries the same types of risks as other x-ray procedures. The radiation dose the patient receives varies depending on the individual procedure, but is generally less than that received during fluoroscopy and computed tomography procedures.

The major risks associated with radiography are the small possibilities of

developing a radiation-induced cancer or cataracts some time later in life, and
	causing a disturbance in the growth or development of an embryo or fetus (teratogenic defect) when performed on a pregnant patient or one of childbearing age.When an individual has a medical need, the benefit of radiography far exceeds the small cancer risk associated with the procedure. Even when radiography is medically necessary, it should use the lowest possible exposure and the minimum number of images. In most cases many of the possible risks can be reduced or eliminated with proper shielding.

Information for Patients

RadiologyInfo: The Radiology Information Resource for PatientsInformation for Professionals

Recommendation for quality assurance programs in diagnostic radiology facilities
	CDRH Organ Dose handbooks containing reference values of radiation doses absorbed in tissues of patients undergoing representative procedures
	Recommendation for the use of specific area gonad shielding on patients during medical diagnostic x-ray proceduresLaws, 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 diagnostic 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:

1000 - General

1002 - Records and Reports

1003 - Notification of defects or failure to comply

1004 - Repurchase, repairs, or replacement of electronic products

1005 - Importation of electronic products

In addition, fluoroscopy 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 (for spot film devices)

Because they are medical devices, radiographic equipment must also comply with the medical device regulations. For more information, see Getting to Market with a Medical Device.

Required Reports for the Radiography Manufacturers or Industry

FDA eSubmitter
	Submitting Reports and Requirements for Maintaining Records for RadiationIndustry Guidance - Documents of Interest

Routine Compliance Testing Procedures for Diagnostic X-Ray Systems
	Resource Manual for Compliance Test Parameters of Diagnostic X-Ray Systems
	Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems; Guidance for Industry and FDA Staff
	FDA Issues Amendments to the Federal Radiation Safety Performance Standard for Diagnostic X-Ray Systems
	Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221)
	A Guide for the Submission of Initial Reports on Diagnostic X-ray Systems and Their Major Components
	Guidance for Industry and FDA Staff - Addition of URLs to Electronic Product Labeling
	Variance Application ProcessOther Resources

Does the Product Emit Radiation?
	How to Study and Market Your Device
	Records and Reporting (Radiation-Emitting Products)
	Importing and Exporting Electronic Products

                                                                                  Content current as of:
      09/28/2020Medical X-ray Imaging

          
                        Radiography
          Computed Tomography (CT)
          Dental Cone-beam Computed Tomography
          Fluoroscopy
          Mammography
 
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