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 CIVCO Medical Instruments Co., Inc., Olympus Medical Systems Corporation and Advance Medical Designs, Inc..
FDA 510(k) Cleared Transducer, Ultrasonic, Diagnostic Devices (Product Code ITX)
About Product Code ITX - Regulatory Context
510(k) Submission Activity
409 total 510(k) submissions under product code ITX since 1978, with 409 receiving FDA clearance (average review time: 152 days).
Submission volume has remained relatively stable over the observed period, with 7 submissions in the last 24 months.
FDA Review Time
Recent submissions under ITX have taken an average of 128 days to reach a decision - down from 152 days historically, suggesting improved FDA processing for this classification.
ITX devices are reviewed by the Radiology panel. Browse all Radiology devices →