IYNClass II

System, Imaging, Pulsed Doppler, Ultrasonic

21 CFR 892.1550 / Radiology

IYN is the FDA product code for System, Imaging, Pulsed Doppler, Ultrasonic, a class II device type, regulated under 21 CFR 892.1550. As of 2026-09-10, FDA records hold 1,182 510(k) clearances under this code, the most recent dated 2026-08-24, and 298 recalls.

Classification record

Product code: IYN
Device name: System, Imaging, Pulsed Doppler, Ultrasonic
Regulation: 21 CFR 892.1550
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: 1,185
Ingested recalls: 299

Clearances, product code IYN

By decision year

1,185 clearances under product code IYN with a decision year between 1978 and 2026, 2017 the highest year at 64.

Show the numbers

510(k) clearances under FDA product code IYN by decision year
Year	Clearances
1978	1
1980	5
1981	5
1982	1
1984	4
1985	3
1987	2
1988	4
1989	10
1990	2
1991	4
1992	2
1993	2
1994	12
1995	7
1996	9
1997	9
1998	10
1999	11
2000	22
2001	21
2002	21
2003	26
2004	23
2005	34
2006	30
2007	13
2008	25
2009	18
2010	29
2011	39
2012	43
2013	51
2014	56
2015	54
2016	60
2017	64
2018	59
2019	47
2020	57
2021	46
2022	53
2023	44
2024	50
2025	57
2026	40

Applicants with the most clearances

Product code IYN

Applicants holding the most 510(k) clearances under product code IYN
Applicant	Clearances
GE Healthcare	132
Shenzhen Mindray Bio-Medical Electronics Co.,LTD	83
Siemens Medical Solutions USA, Inc.	76
Samsung Medison Co., Ltd.	68
Philips North America LLC	58
FUJIFILM SonoSite,Inc.	41
Esaote S.p.A.	34
ALPINION MEDICAL SYSTEMS Co., Ltd.	25
General Electric Co.	23
Toshiba America Medical Systems, In.C	22

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 201 companies shown, in name order