FDA 510(k) clearance for ADAC Laboratories:
This article was originally published in Clinica
Executive Summary
The FDA has given ADAC Laboratories 510(k) clearance to market molecular coincidence detection with attenuation correction (MCD/ACTM) for use with its gamma cameras. MCD/AC is a further development to ADAC's MCD system which corrects image distortions created by non-uniform attenuation of soft tissue in the human body. The technology allows the company's nuclear medicine imaging systems to perform both single photon emission computed tomography and coincidence imaging. Coincidence imaging was previously confined to being available on expensive, dedicated positron emission tomography systems only.