ITXClass II

Transducer, Ultrasonic, Diagnostic

21 CFR 892.1570 / Radiology

ITX is the FDA product code for Transducer, Ultrasonic, Diagnostic, a class II device type, regulated under 21 CFR 892.1570. As of 2026-09-10, FDA records hold 414 510(k) clearances under this code, the most recent dated 2026-08-12, and 147 recalls.

Classification record

Product code: ITX
Device name: Transducer, Ultrasonic, Diagnostic
Regulation: 21 CFR 892.1570
Device class: Class II
Review panel: Radiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 415
Ingested recalls: 147

Clearances, product code ITX

By decision year

415 clearances under product code ITX with a decision year between 1978 and 2026, 1991 the highest year at 30.

Show the numbers

510(k) clearances under FDA product code ITX by decision year
Year	Clearances
1978	2
1980	2
1981	6
1982	1
1983	1
1984	1
1985	13
1986	24
1987	18
1988	3
1989	3
1990	16
1991	30
1992	29
1993	8
1994	6
1995	17
1996	14
1997	27
1998	15
1999	13
2000	8
2001	12
2002	6
2003	5
2004	11
2005	5
2006	5
2007	10
2008	12
2009	17
2010	10
2011	10
2012	7
2013	3
2014	4
2015	1
2016	4
2017	6
2018	2
2019	1
2020	3
2021	3
2022	2
2023	6
2024	3
2025	4
2026	6

Applicants with the most clearances

Product code ITX

Applicants holding the most 510(k) clearances under product code ITX
Applicant	Clearances
CIVCO Medical Instruments Co., Inc.	15
Biosound, Inc.	13
Acuson Corp.	11
Boston Scientific Corporation	11
General Electric Co.	11
Acuson Computed Sonography	10
Toshiba America Medical Systems, In.C	9
Toshiba Medical Systems	9
Aloka Co., Ltd.	8
Diasonics, Inc.	8

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 357 companies shown, in name order