LLZClass II

System, Image Processing, Radiological

21 CFR 892.2050 / Radiology

LLZ is the FDA product code for System, Image Processing, Radiological, a class II device type, regulated under 21 CFR 892.2050. As of 2026-09-10, FDA records hold 2,286 510(k) clearances under this code, the most recent dated 2026-08-17, and 554 recalls.

Classification record

Product code: LLZ
Device name: System, Image Processing, Radiological
Regulation: 21 CFR 892.2050
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: 2,292
Ingested recalls: 560

Clearances, product code LLZ

By decision year

2,292 clearances under product code LLZ with a decision year between 1983 and 2026, 2011 the highest year at 106.

Show the numbers

510(k) clearances under FDA product code LLZ by decision year
Year	Clearances
1983	1
1985	8
1986	6
1987	11
1988	8
1989	17
1990	12
1991	9
1992	13
1993	12
1994	9
1995	23
1996	30
1997	29
1998	36
1999	31
2000	47
2001	41
2002	56
2003	67
2004	99
2005	92
2006	103
2007	76
2008	94
2009	70
2010	51
2011	106
2012	82
2013	95
2014	78
2015	64
2016	82
2017	78
2018	104
2019	74
2020	81
2021	83
2022	65
2023	87
2024	62
2025	58
2026	42

Applicants with the most clearances

Product code LLZ

Applicants holding the most 510(k) clearances under product code LLZ
Applicant	Clearances
Siemens Medical Solutions USA, Inc.	76
Philips North America LLC	67
GE Healthcare	50
Totoku Electric Co., Ltd.	40
Canon Medical Informatics, Inc.	35
Eizo Nanao Corporation	34
FUJIFILM Healthcare Americas Corporation	33
Barco N.V.	29
Ewoosoft Co., Ltd	29
Eastman Kodak Company	22

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 565 companies shown, in name order