FDA Product Code KPS: System, Tomography, Computed, Emission

Emission computed tomography enables clinicians to visualize metabolic and physiological processes in vivo. FDA product code KPS covers emission CT systems — including PET (positron emission tomography) and SPECT (single-photon emission computed tomography) scanners.

These systems detect gamma rays emitted by radiotracers administered to the patient, generating three-dimensional functional images of organ activity. They are essential in oncology staging, cardiac viability assessment, and neurological evaluation.

KPS devices are Class II medical devices, regulated under 21 CFR 892.1200 and reviewed by the FDA Radiology panel.

Leading manufacturers include Shanghai United Imaging Healthcare Co., Ltd., Siemens Medical Solutions USA, Inc. and Ge Healthcare.