Tomography Scanner Cleared by FDA for Colonography

An electron beam tomography (EBT) scanner has been cleared by the U.S. Food and Drug Administration (FDA) for colonography, a minimally invasive procedure permitting visualization of the interior surface of the colon from the perspective of a virtual fly-through mode.

The EBT scanner is the product of Imatron Inc. (So. San Francisco, CA, USA), which states that it is the only computed tomography (CT) scanner specifically cleared by the FDA for colonographic use. The EBT scanner is intended to function as a diagnostic x-ray system to produce two- and three-dimensional images of human anatomical cavities. The scanner permits radiologic visualization of cavities and vessels during or after the injection of a contrast medium or inflation with gases such as air or carbon dioxide. Every Imatron EBT scanner is capable of utilizing the EBT's scanner's colonographic capabilities without any modification or upgrade to the system.

"The FDA's market clearance for Imatron's EB-colonography clinical application further expands a broad range of recent specific FDA clearances for the Imatron EBT scanner, including coronary artery scanning, electron beam angiography (EBA), and low-dose lung scanning,” noted S. Lewis Meyer, CEO of Imatron.



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