FDA Product Code JAA: System, X-ray, Fluoroscopic, Image-intensified
Leading manufacturers include Philips Medical Systems Dmc GmbH, Dornier Medtech America, Inc. and Canon Medical Systems Corporation.
FDA 510(k) Cleared System, X-ray, Fluoroscopic, Image-intensified Devices (Product Code JAA)
About Product Code JAA - Regulatory Context
510(k) Submission Activity
299 total 510(k) submissions under product code JAA since 1976, with 299 receiving FDA clearance (average review time: 88 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under JAA have taken an average of 151 days to reach a decision - up from 88 days historically. Manufacturers should account for longer review timelines in current project planning.
JAA devices are reviewed by the Radiology panel. Browse all Radiology devices →