JAKClass II

System, X-Ray, Tomography, Computed

21 CFR 892.1750 / Radiology

JAK is the FDA product code for System, X-Ray, Tomography, Computed, a class II device type, regulated under 21 CFR 892.1750. As of 2026-09-10, FDA records hold 822 510(k) clearances under this code, the most recent dated 2026-07-28, and 864 recalls.

Classification record

Product code: JAK
Device name: System, X-Ray, Tomography, Computed
Regulation: 21 CFR 892.1750
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: 825
Ingested recalls: 871

Clearances, product code JAK

By decision year

825 clearances under product code JAK with a decision year between 1976 and 2026, 2014 the highest year at 30.

Show the numbers

510(k) clearances under FDA product code JAK by decision year
Year	Clearances
1976	7
1977	11
1978	13
1979	8
1980	5
1981	11
1982	1
1983	1
1984	3
1985	5
1986	5
1987	5
1988	15
1989	10
1990	11
1991	14
1992	12
1993	6
1994	12
1995	6
1996	11
1997	19
1998	18
1999	14
2000	13
2001	23
2002	16
2003	21
2004	19
2005	17
2006	25
2007	14
2008	26
2009	15
2010	7
2011	16
2012	28
2013	17
2014	30
2015	30
2016	25
2017	29
2018	24
2019	28
2020	30
2021	20
2022	30
2023	27
2024	26
2025	27
2026	19

Applicants with the most clearances

Product code JAK

Applicants holding the most 510(k) clearances under product code JAK
Applicant	Clearances
Siemens Medical Solutions USA, Inc.	120
GE Healthcare	75
Philips North America LLC	46
Toshiba America Medical Systems, In.C	35
General Electric Co.	31
Toshibamedical Systems Corporation	27
Canon Medical Systems Corporation	23
FUJIFILM Healthcare Americas Corporation	19
Elscint, Inc.	16
GE Medical Systems SCS	16

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 149 companies shown, in name order