IZFClass II

System, X-Ray, Tomographic

21 CFR 892.1740 / Radiology

IZF is the FDA product code for System, X-Ray, Tomographic, a class II device type, regulated under 21 CFR 892.1740. As of 2026-09-10, FDA records hold 42 510(k) clearances under this code, the most recent dated 2026-02-02, and 6 recalls.

Classification record

Product code: IZF
Device name: System, X-Ray, Tomographic
Regulation: 21 CFR 892.1740
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: 42
Ingested recalls: 6

Clearances, product code IZF

By decision year

42 clearances under product code IZF with a decision year between 1976 and 2026, 1979 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code IZF by decision year
Year	Clearances
1976	1
1977	3
1978	3
1979	4
1981	4
1983	1
1985	1
1989	3
1992	1
1993	2
1994	2
1995	2
1998	2
2001	1
2002	1
2012	1
2013	1
2019	1
2020	1
2021	1
2023	2
2024	1
2025	2
2026	1

Applicants with the most clearances

Product code IZF

Applicants holding the most 510(k) clearances under product code IZF
Applicant	Clearances
Philips North America LLC	5
Nano-X Imaging Ltd	4
Siemens Corp.	4
Agfa N.V.	2
Continental X-Ray Corp.	2
GE Healthcare	2
Pausch Corp.	2
Tecnomed, Inc.	2
Toshiba Medical Systems	2
Adaptix Limited	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order