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 General Electric Co., Boston Scientific Corp and Siemens Medical Solutions USA, Inc..
409
Total
409
Cleared
152d
Avg days
1978
Since
Stable submission activity - 7 submissions in the last 2 years
Review times improving: avg
128d
recently vs 152d historically
FDA 510(k) Cleared Transducer, Ultrasonic, Diagnostic Devices (Product Code ITX)
409 devices
Cleared
Sep 18, 2025
ULTRASONIC PROBE UM-3R (UM-3R)
Olympus Medical Systems Corporation
Radiology
178d
Cleared
Jul 11, 2025
ULTRASONIC PROBE UM-S20-17S (UM-S20-17S)
Olympus Medical Systems Corporation
Radiology
120d
Cleared
Jul 02, 2025
Mendaera Guidance System
Mendaera, Inc.
Radiology
131d
Cleared
Jun 13, 2025
Accuro® 3S Needle Guide Kit
Rivanna Medical, Inc.
Radiology
115d
Cleared
Aug 30, 2024
Ultrasound Transducer Cover
Vitrolife Sweden AB
Radiology
81d
Cleared
Aug 15, 2024
UltraDrape UGPIV Barrier and Securement (34-15)
Parker Laboratories, Inc.
Radiology
244d
Cleared
Jul 03, 2024
Transducer Probe Cover
Hony Medical Co., Ltd.
Radiology
28d
Cleared
Dec 22, 2023
TP Pivot Pro™ Needle Guide
Civco Medical Solutions
Radiology
86d
Cleared
Dec 13, 2023
Endoscopic Ultrasonic Probe (P2612S-L)
Fujifilm Healthcare Americas Corporation
Radiology
189d
Cleared
Nov 14, 2023
VitroPRO
CIVCO Medical Instruments Co., Inc.
Radiology
151d
Cleared
Aug 02, 2023
Disposable Needle Guides and Grids
Advance Medical Designs, Inc.
Radiology
236d
Cleared
May 12, 2023
Intraoperative Ultrasound Probe Cover
Exact Medical Manufacturing
Radiology
270d
Cleared
Jan 11, 2023
Transducer Probe Cover
Hony Medical Co., Ltd.
Radiology
253d
Cleared
Nov 22, 2022
VitroPRO
CIVCO Medical Instruments Co., Inc.
Radiology
133d
Cleared
Jun 07, 2022
Natural Rubber Latex Ultrasound Transducer Probe Covers
Global Protection Corp.
Radiology
256d
Cleared
Sep 13, 2021
CIV-Clear cover
CIVCO Medical Instruments Co., Inc.
Radiology
139d
Cleared
Aug 13, 2021
EMM Ultrasonic Transducer Cover
Exact Medical Manufacturing
Radiology
50d
Cleared
Feb 19, 2021
Disposable Intraoperative Probe (DIOP8)
Huntleigh Healthcare Limited
Radiology
266d
Cleared
Nov 20, 2020
Vscan Air
GE Medical Systems Ultrasound and Primary Care Diagnostics
Radiology
120d
Cleared
Jun 05, 2020
EZ-Cover
Medxpress.Pro
Radiology
366d
Cleared
Apr 17, 2020
Opticross 35 15 MHz Peripheral Imaging Catheter
Boston Scientific Corporation
Cardiovascular
28d
Cleared
May 24, 2019
Envision ultrasound pad and cover
Civco Medical Solutions
Radiology
56d
Cleared
Jul 17, 2018
Cook-Swartz Doppler Flow Probe
Cook Incorporated
Radiology
442d
Cleared
Jul 10, 2018
Disposable guides KDNG00
Koelis
Radiology
88d
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 510(k) Review Time - ITX Product Code
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 →