IYOClass II

System, Imaging, Pulsed Echo, Ultrasonic

21 CFR 892.1560 / Radiology

IYO is the FDA product code for System, Imaging, Pulsed Echo, Ultrasonic, a class II device type, regulated under 21 CFR 892.1560. As of 2026-09-10, FDA records hold 894 510(k) clearances under this code, the most recent dated 2026-07-24, and 82 recalls.

Classification record

Product code: IYO
Device name: System, Imaging, Pulsed Echo, Ultrasonic
Regulation: 21 CFR 892.1560
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: 895
Ingested recalls: 83

Clearances, product code IYO

By decision year

895 clearances under product code IYO with a decision year between 1977 and 2026, 1988 the highest year at 46.

Show the numbers

510(k) clearances under FDA product code IYO by decision year
Year	Clearances
1977	7
1978	8
1979	19
1980	33
1981	25
1982	12
1983	3
1984	36
1985	36
1986	41
1987	14
1988	46
1989	32
1990	23
1991	14
1992	17
1993	19
1994	19
1995	18
1996	29
1997	23
1998	20
1999	31
2000	17
2001	18
2002	16
2003	13
2004	17
2005	15
2006	13
2007	20
2008	14
2009	13
2010	15
2011	11
2012	15
2013	17
2014	14
2015	19
2016	10
2017	19
2018	14
2019	13
2020	11
2021	15
2022	5
2023	11
2024	10
2025	7
2026	8

Applicants with the most clearances

Product code IYO

Applicants holding the most 510(k) clearances under product code IYO
Applicant	Clearances
Siemens Medical Solutions USA, Inc.	31
General Electric Co.	21
Advanced Technology Laboratories, Inc.	20
Volcano Corporation	19
Hewlett-Packard Co.	14
Ausonics Pty, Ltd.	12
Hitachi Medical Corp. of America	12
Toshiba Medical Systems	12
Echosens	11
GE Healthcare	11

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 311 companies shown, in name order