IZHClass II

System, X-Ray, Mammographic

21 CFR 892.1710 / Radiology

IZH is the FDA product code for System, X-Ray, Mammographic, a class II device type, regulated under 21 CFR 892.1710. As of 2026-09-10, FDA records hold 176 510(k) clearances under this code, the most recent dated 2021-07-14, and 14 recalls.

Classification record

Product code: IZH
Device name: System, X-Ray, Mammographic
Regulation: 21 CFR 892.1710
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: 176
Ingested recalls: 14

Clearances, product code IZH

By decision year

176 clearances under product code IZH with a decision year between 1977 and 2021, 1995 the highest year at 15.

Show the numbers

510(k) clearances under FDA product code IZH by decision year
Year	Clearances
1977	1
1979	1
1983	2
1984	3
1985	4
1986	5
1987	8
1988	9
1989	11
1990	6
1991	7
1992	13
1993	4
1994	14
1995	15
1996	4
1997	10
1998	7
1999	8
2000	4
2001	7
2002	4
2003	5
2004	4
2005	1
2006	1
2007	3
2008	1
2010	2
2011	1
2012	2
2013	2
2015	1
2016	3
2019	1
2020	1
2021	1

Applicants with the most clearances

Product code IZH

Applicants holding the most 510(k) clearances under product code IZH
Applicant	Clearances
Hologic, Inc.	11
Lorad Corp.	11
Planmed Oy	11
Elscint, Inc.	10
Fischer Imaging Corp.	8
Bennett X-Ray Corp.	7
Instrumentarium Imaging, Inc.	6
Philips North America LLC	6
Siemens Medical Solutions USA, Inc.	6
Lorad Medical Systems, Inc.	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 25 companies shown, in name order