FDA Product Code ITX: Transducer, Ultrasonic, Diagnostic

FDA product code ITX covers diagnostic ultrasonic transducers — the probes that generate and receive ultrasound waves in imaging systems.

These devices convert electrical energy into high-frequency sound waves that penetrate tissue and reflect back to create real-time images of internal structures. Transducers are available in linear, convex, phased array, and endocavitary configurations for different anatomical applications.

ITX devices are Class II medical devices, regulated under 21 CFR 892.1570 and reviewed by the FDA Radiology panel.

Leading manufacturers include Biosound, Inc., General Electric Co. and Acuson Corp..