KPQClass II

System, Simulation, Radiation Therapy

21 CFR 892.5840 / Radiology

KPQ is the FDA product code for System, Simulation, Radiation Therapy, a class II device type, regulated under 21 CFR 892.5840. As of 2026-09-10, FDA records hold 70 510(k) clearances under this code, the most recent dated 2014-03-14, and 13 recalls.

Classification record

Product code: KPQ
Device name: System, Simulation, Radiation Therapy
Regulation: 21 CFR 892.5840
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: 70
Ingested recalls: 13

Clearances, product code KPQ

By decision year

70 clearances under product code KPQ with a decision year between 1976 and 2014, 1989 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code KPQ by decision year
Year	Clearances
1976	2
1977	1
1978	4
1981	4
1983	1
1985	5
1986	2
1987	2
1989	6
1990	2
1991	6
1992	6
1993	1
1995	4
1996	2
1997	3
1998	2
2000	1
2001	1
2002	3
2003	2
2004	1
2005	2
2006	1
2007	1
2008	1
2009	1
2010	1
2013	1
2014	1

Applicants with the most clearances

Product code KPQ

Applicants holding the most 510(k) clearances under product code KPQ
Applicant	Clearances
Varian Assoc., Inc.	6
Nucletron BV	5
Elekta Limited	4
Varian Medical Systems, Inc.	4
Philips North America LLC	3
Siemens Medical Solutions USA, Inc.	3
Victoreen, Inc.	3
GE Healthcare	2
GE Hungary Kft	2
Haynes Radiation Ltd., Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code