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.
FDA 510(k) Cleared System, Tomography, Computed, Emission Devices (Product Code KPS)
About Product Code KPS - Regulatory Context
510(k) Submission Activity
470 total 510(k) submissions under product code KPS since 1977, with 470 receiving FDA clearance (average review time: 84 days).
Submission volume has increased in recent years - 24 submissions in the last 24 months compared to 18 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for KPS submissions have been consistent, averaging 84 days recently vs 84 days historically.
KPS devices are reviewed by the Radiology panel. Browse all Radiology devices →