FDA Product Code JAK: System, X-ray, Tomography, Computed
FDA product code JAK covers computed tomography (CT) systems.
These diagnostic imaging systems use rotating X-ray beams and computer processing to generate detailed cross-sectional and three-dimensional images of the body. CT is widely used in emergency medicine, oncology, cardiology, and surgical planning.
JAK devices are Class II medical devices, regulated under 21 CFR 892.1750 and reviewed by the FDA Radiology panel.
Leading manufacturers include Siemens Medical Solutions USA, Inc., Canon Medical Systems Corporation and Shanghai United Imaging Healthcare Co., Ltd..
FDA 510(k) Cleared System, X-ray, Tomography, Computed Devices (Product Code JAK)
About Product Code JAK - Regulatory Context
510(k) Submission Activity
817 total 510(k) submissions under product code JAK since 1976, with 817 receiving FDA clearance (average review time: 107 days).
Submission volume has remained relatively stable over the observed period, with 49 submissions in the last 24 months.
FDA Review Time
Recent submissions under JAK have taken an average of 145 days to reach a decision - up from 104 days historically. Manufacturers should account for longer review timelines in current project planning.
JAK devices are reviewed by the Radiology panel. Browse all Radiology devices →