- Information for Users and the Public
- Laws, Regulations & Standards
- Industry Guidance
- Other Resources
A cabinet x-ray system contains an x-ray tube installed within a shielded enclosure. The enclosure is made of a material, usually lead, that stops most of the x radiation from leaving the enclosure. The enclosure also serves as a physical barrier that excludes people from the space where x-rays are produced.
Cabinet x-ray systems create images of the inside of products, parcels and luggage without damaging their contents. As an item passes through the cabinet, the x-ray image is transmitted to a monitor.
Cabinet x-ray systems are sometimes referred to as closed x-ray systems, x-ray inspection systems, x-ray screening systems, x-ray security systems, and baggage x-ray systems.
Cabinet x-ray systems are primarily used for security screening and industrial quality control. Some examples include:
- Airport baggage security screening
- Cargo inspection of trucks crossing international borders
- Food inspection to check for foreign objects
- Circuit board inspection to find manufacturing defects
- Tire inspection to identify manufacturing defects
Some cabinet x-ray systems are used for medical applications, such as analyzing tissue samples for tumor metastases. These systems are medical devices and subject to additional FDA regulations.
Cabinet x-ray systems allow inspection of the interior of various items. This enables detection of contraband, contaminants, and manufacturing defects without damaging or destroying the item being examined.
The FDA’s radiation safety performance standard for cabinet x-ray systems requires that external radiation emission from a cabinet x-ray system not exceed an exposure of 0.5 milliroentgens in one hour. Most cabinet x-ray systems emit less than this limit. In addition, the standard also requires safety features that include warning lights, warning labels, and interlocks to protect users and the public from radiation emissions.
- Frequently Asked Questions on Cabinet X-ray Systems (March 24, 2003)
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 cabinet x-ray systems 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, cabinet x-ray systems must comply with radiation safety performance standards in Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1010 and 1020.40:
Use of cabinet x-ray products is regulated either by the U.S. Occupational Safety & Health Administration or by State Government.
Cabinet x-ray systems that are used for medical applications must also comply with the medical device regulations. For more information, see Getting to Market with a Medical Device.
Required Reports for the Cabinet X-Ray Manufacturers or Industry
- Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40
- Guide for Filling Annual Reports for X-Ray Components and Systems
- FDA eSubmitter
Industry Guidance - Other Documents of Interest
- Guidance for Industry and FDA Staff - Addition of URLs to Electronic Product Labeling
- Compliance Guide for Cabinet X-Ray Systems
- Variance Application Process
- Getting a Radiation Emitting Product to Market
- Records and Reporting (Radiation-Emitting Products)
- Importing and Exporting Electronic Products
- Routine Compliance Testing for Cabinet X-ray Systems to which 21 CFR Subchapter J is Applicable
- Does the Product Emit Radiation?