Is a CT scan a medical device?
CT imaging systems are Class II medical devices.
What CT means in medical terms?
Computed tomography (CT) scan of the abdomen. The patient lies on a table that slides through the CT machine, which takes x-ray pictures of the inside of the body.
What device is used for CT scan?
The CT scanner is typically a large, donut-shaped machine with a short tunnel in the center. You will lie on a narrow table that slides in and out of this short tunnel. Rotating around you, the x-ray tube and electronic x-ray detectors are located opposite each other in a ring, called a gantry.
What is CT component?
CT scanners are composed of three important elements: an X-ray tube, a gantry with a ring of X-ray sensitive detectors, and a computer. In this method, images are created using the same physics principles as in conventional radiography.
What is CT console?
A CT scan uses large two-dimensional x-rays to form a three-dimensional image. Multiple images are processed by sophisticated computer software to create a cross-section view of the body.
How are CT devices regulated by the FDA?
The FDA regulates manufacturers of CT devices through the Electronic Product Radiation Control (EPRC) and medical device provisions of federal law. CT devices are classified under 21 CFR 892.1750. The EPRC requirements and guidance specific to CT devices include:
What are the regulations for computed tomography ( CT )?
The FDA has regulations covering the safety and effectiveness and radiation control of all X-ray imaging devices, including CT. Individual states and other federal agencies regulate the use of CT devices through recommendations and requirements for personnel qualifications, quality assurance and quality control programs, and facility accreditation.
What is the abbreviation for computerized tomography ( CT )?
Computed tomography (CT), sometimes called “computerized tomography” or “computed axial tomography” (CAT), is a noninvasive medical examination or procedure that uses specialized X-ray equipment to produce cross-sectional images of the body.
How is a CT scan performed in a hospital?
Most CT scans are performed as outpatient procedures. A motorized table moves the patient through a circular opening in the CT imaging system. While the patient is inside the opening, an X-ray source and a detector assembly within the system rotate around the patient.