KPRClass II

System, X-Ray, Stationary

21 CFR 892.1680 / Radiology

KPR is the FDA product code for System, X-Ray, Stationary, a class II device type, regulated under 21 CFR 892.1680. As of 2026-09-10, FDA records hold 357 510(k) clearances under this code, the most recent dated 2026-08-27, and 168 recalls.

Classification record

Product code: KPR
Device name: System, X-Ray, Stationary
Regulation: 21 CFR 892.1680
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: 359
Ingested recalls: 168

Clearances, product code KPR

By decision year

359 clearances under product code KPR with a decision year between 1976 and 2026, 2015 the highest year at 18.

Show the numbers

510(k) clearances under FDA product code KPR by decision year
Year	Clearances
1976	1
1977	2
1978	3
1979	6
1980	3
1981	11
1984	3
1985	3
1986	5
1987	6
1988	5
1989	1
1990	7
1991	5
1992	8
1993	8
1994	11
1995	7
1996	2
1997	5
1998	11
1999	7
2000	3
2001	6
2002	4
2003	2
2004	3
2005	7
2006	8
2007	12
2008	15
2009	9
2010	9
2011	9
2012	11
2013	5
2014	10
2015	18
2016	11
2017	6
2018	15
2019	12
2020	16
2021	6
2022	8
2023	9
2024	11
2025	8
2026	6

Applicants with the most clearances

Product code KPR

Applicants holding the most 510(k) clearances under product code KPR
Applicant	Clearances
Samsung Electronics Co., Ltd.	20
Eastman Kodak Company	14
Siemens Medical Solutions USA, Inc.	14
Philips North America LLC	13
Imaging Dynamics Company, Ltd.	11
GE Healthcare	10
Octostop, Inc.	8
Shimadzu Corp.	8
GE Hualun Medical Systems Co., Ltd.	7
Siemens Corp.	7

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 78 companies shown, in name order