JAAClass II

System, X-Ray, Fluoroscopic, Image-Intensified

21 CFR 892.1650 / Radiology

JAA is the FDA product code for System, X-Ray, Fluoroscopic, Image-Intensified, a class II device type, regulated under 21 CFR 892.1650. As of 2026-09-10, FDA records hold 300 510(k) clearances under this code, the most recent dated 2026-05-29, and 223 recalls.

Classification record

Product code: JAA
Device name: System, X-Ray, Fluoroscopic, Image-Intensified
Regulation: 21 CFR 892.1650
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: 300
Ingested recalls: 223

Clearances, product code JAA

By decision year

300 clearances under product code JAA with a decision year between 1976 and 2026, 1992 the highest year at 22.

Show the numbers

510(k) clearances under FDA product code JAA by decision year
Year	Clearances
1976	1
1977	5
1978	1
1979	2
1980	5
1981	11
1982	4
1983	5
1984	11
1985	7
1986	6
1987	10
1988	12
1989	15
1990	16
1991	11
1992	22
1993	14
1994	13
1995	15
1996	14
1997	9
1998	6
1999	3
2000	2
2001	6
2002	5
2003	1
2004	2
2005	6
2006	1
2007	1
2008	6
2010	1
2011	4
2012	1
2013	6
2014	6
2015	3
2016	2
2017	1
2018	3
2019	6
2020	4
2021	6
2022	1
2023	2
2024	3
2025	2
2026	1

Applicants with the most clearances

Product code JAA

Applicants holding the most 510(k) clearances under product code JAA
Applicant	Clearances
Philips North America LLC	21
Toshiba America Medical Systems, In.C	13
Siemens Medical Solutions USA, Inc.	11
Fischer Imaging Corp.	10
General Electric Co.	10
Shimadzu Medical Systems	10
Eigen	9
Shimadzu Corp.	9
Omega Medical Imaging, LLC	8
Dornier Medtech America, Inc.	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 125 companies shown, in name order