FDA Product Code JAD: System, Therapeutic, X-ray
Leading manufacturers include Carl Zeiss Meditec, AG and Voxel Ray Solutions, LLC.
FDA 510(k) Cleared System, Therapeutic, X-ray Devices (Product Code JAD)
About Product Code JAD - Regulatory Context
510(k) Submission Activity
53 total 510(k) submissions under product code JAD since 1978, with 53 receiving FDA clearance (average review time: 119 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under JAD have taken an average of 265 days to reach a decision - up from 114 days historically. Manufacturers should account for longer review timelines in current project planning.
JAD devices are reviewed by the Radiology panel. Browse all Radiology devices →