KGIClass II

Densitometer, Bone

21 CFR 892.1170 / Radiology

KGI is the FDA product code for Densitometer, Bone, a class II device type, regulated under 21 CFR 892.1170. As of 2026-09-10, FDA records hold 147 510(k) clearances under this code, the most recent dated 2026-04-20, and 26 recalls.

Classification record

Product code: KGI
Device name: Densitometer, Bone
Regulation: 21 CFR 892.1170
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: 148
Ingested recalls: 26

Clearances, product code KGI

By decision year

148 clearances under product code KGI with a decision year between 1979 and 2026, 1998 the highest year at 15.

Show the numbers

510(k) clearances under FDA product code KGI by decision year
Year	Clearances
1979	1
1980	2
1981	2
1984	1
1985	5
1987	6
1988	4
1989	6
1990	9
1991	6
1992	3
1993	1
1994	2
1995	9
1996	5
1997	9
1998	15
1999	6
2000	10
2001	2
2002	4
2003	4
2004	3
2005	1
2006	2
2007	2
2008	5
2009	1
2011	2
2012	5
2013	1
2014	2
2016	2
2018	1
2019	1
2022	2
2023	1
2025	3
2026	2

Applicants with the most clearances

Product code KGI

Applicants holding the most 510(k) clearances under product code KGI
Applicant	Clearances
Hologic, Inc.	29
Lunar Corp.	26
Norland Corp.	15
Image Analysis, Inc.	7
Lunar Radiation Corp.	5
Amersham Corp.	4
GE Healthcare	4
GE Medical Systems Ultrasound and Primary Care Dia	4
GE Lunar Corp.	3
Medimaps Group SA	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order