KPSClass II

System, Tomography, Computed, Emission

21 CFR 892.1200 / Radiology

KPS is the FDA product code for System, Tomography, Computed, Emission, a class II device type, regulated under 21 CFR 892.1200. As of 2026-09-10, FDA records hold 472 510(k) clearances under this code, the most recent dated 2026-07-28, and 443 recalls.

Classification record

Product code: KPS
Device name: System, Tomography, Computed, Emission
Regulation: 21 CFR 892.1200
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: 473
Ingested recalls: 449

Clearances, product code KPS

By decision year

473 clearances under product code KPS with a decision year between 1977 and 2026, 2004 the highest year at 28.

Show the numbers

510(k) clearances under FDA product code KPS by decision year
Year	Clearances
1977	1
1978	1
1979	2
1981	2
1984	1
1985	2
1986	1
1987	1
1988	3
1989	7
1990	2
1991	15
1992	24
1993	11
1994	13
1995	17
1996	17
1997	20
1998	20
1999	15
2000	15
2001	10
2002	15
2003	20
2004	28
2005	13
2006	11
2007	8
2008	17
2009	9
2010	3
2011	7
2012	6
2013	11
2014	11
2015	3
2016	11
2017	11
2018	13
2019	3
2020	12
2021	15
2022	5
2023	12
2024	11
2025	12
2026	6

Applicants with the most clearances

Product code KPS

Applicants holding the most 510(k) clearances under product code KPS
Applicant	Clearances
Siemens Medical Solutions USA, Inc.	64
Philips North America LLC	55
GE Healthcare	39
Shanghai United Imaging Healthcare Co., Ltd.	18
Trionix Research Laboratory, Inc.	16
GE Medical Systems F.I. Haifa	14
Hermes Medical Solutions AB	13
Syntermed, Inc.	13
Digirad Corp.	10
General Electric Co.	9

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 78 companies shown, in name order