IYEClass II

Accelerator, Linear, Medical

21 CFR 892.5050 / Radiology

IYE is the FDA product code for Accelerator, Linear, Medical, a class II device type, regulated under 21 CFR 892.5050. As of 2026-09-10, FDA records hold 736 510(k) clearances under this code, the most recent dated 2026-08-26, and 562 recalls.

Classification record

Product code: IYE
Device name: Accelerator, Linear, Medical
Regulation: 21 CFR 892.5050
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: No
Ingested clearances: 738
Ingested recalls: 563

Clearances, product code IYE

By decision year

738 clearances under product code IYE with a decision year between 1977 and 2026, 1995 the highest year at 33.

Show the numbers

510(k) clearances under FDA product code IYE by decision year
Year	Clearances
1977	5
1978	4
1979	4
1980	5
1981	3
1982	2
1983	6
1984	1
1985	1
1986	5
1987	4
1988	11
1989	10
1990	7
1991	11
1992	6
1993	13
1994	29
1995	33
1996	26
1997	28
1998	26
1999	17
2000	15
2001	23
2002	13
2003	22
2004	11
2005	13
2006	19
2007	23
2008	14
2009	20
2010	23
2011	11
2012	28
2013	18
2014	20
2015	20
2016	21
2017	23
2018	21
2019	19
2020	20
2021	19
2022	12
2023	18
2024	9
2025	12
2026	14

Applicants with the most clearances

Product code IYE

Applicants holding the most 510(k) clearances under product code IYE
Applicant	Clearances
Varian Medical Systems, Inc.	85
Elekta Limited	32
Varian Assoc., Inc.	27
Brainlab, Inc.	23
Medtec LLC	23
Accuray Incorporated	21
Philips North America LLC	20
Sun Nuclear Corporation	19
Siemens Medical Solutions USA, Inc.	18
Vision Rt Inc	11

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 107 companies shown, in name order