IYXClass I

Camera, Scintillation (Gamma)

21 CFR 892.1100 / Radiology

IYX is the FDA product code for Camera, Scintillation (Gamma), a class I device type, regulated under 21 CFR 892.1100. As of 2026-09-10, FDA records hold 130 510(k) clearances under this code, the most recent dated 2023-08-28, and 7 recalls.

Classification record

Product code: IYX
Device name: Camera, Scintillation (Gamma)
Regulation: 21 CFR 892.1100
Device class: Class I
Review panel: Radiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 130
Ingested recalls: 7

Clearances, product code IYX

By decision year

130 clearances under product code IYX with a decision year between 1976 and 2023, 1978 the highest year at 11.

Show the numbers

510(k) clearances under FDA product code IYX by decision year
Year	Clearances
1976	1
1977	5
1978	11
1979	5
1980	4
1981	6
1982	1
1983	2
1984	7
1985	6
1986	3
1987	5
1988	4
1989	9
1990	5
1991	7
1992	2
1993	9
1994	4
1995	2
1997	1
1999	1
2000	1
2001	1
2002	2
2003	1
2004	2
2005	2
2006	1
2007	2
2008	2
2009	2
2010	4
2011	3
2013	1
2014	1
2016	2
2017	1
2023	2

Applicants with the most clearances

Product code IYX

Applicants holding the most 510(k) clearances under product code IYX
Applicant	Clearances
General Electric Co.	15
Siemens Gammasonics, Inc.	11
Philips North America LLC	9
Elscint, Inc.	5
Medtronic, Inc.	5
Toshiba Medical Systems	5
Union Carbide Corp.	4
Digirad Corp.	3
Dilon Technologies Inc	3
GE Healthcare	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 20 companies shown, in name order