FDA Product Code DXG: Computer, Diagnostic, Pre-programmed, Single-function
Leading manufacturers include Caretaker Medical and Retia Medical Systems, Inc..
FDA 510(k) Cleared Computer, Diagnostic, Pre-programmed, Single-function Devices (Product Code DXG)
About Product Code DXG - Regulatory Context
510(k) Submission Activity
177 total 510(k) submissions under product code DXG since 1976, with 177 receiving FDA clearance (average review time: 130 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
FDA review times for DXG submissions have been consistent, averaging 149 days recently vs 130 days historically.
DXG devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →