FDA Product Code JOP: Transducer, Ultrasonic
Leading manufacturers include Corvascular Diagnostics, LLC and Viasonix , Ltd..
FDA 510(k) Cleared Transducer, Ultrasonic Devices (Product Code JOP)
About Product Code JOP - Regulatory Context
510(k) Submission Activity
72 total 510(k) submissions under product code JOP since 1981, with 72 receiving FDA clearance (average review time: 165 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for JOP submissions have been consistent, averaging 161 days recently vs 165 days historically.
JOP devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →