FDA Product Code JAI: Couch, Radiation Therapy, Powered
Leading manufacturers include Leo Cancer Care.
32
Total
32
Cleared
105d
Avg days
1983
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Couch, Radiation Therapy, Powered Devices (Product Code JAI)
32 devices
About Product Code JAI - Regulatory Context
510(k) Submission Activity
32 total 510(k) submissions under product code JAI since 1983, with 32 receiving FDA clearance (average review time: 105 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
JAI devices are reviewed by the Radiology panel. Browse all Radiology devices →