510(k) · Cleared

Cleared

Hologic QDR-3000 X-Ray Bone Densitometer

K943505510(k) TraditionalCleared Jan 20, 1995184-day reviewClass II21 CFR 892.1170

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cleared on Jan 20, 1995 after a 184-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 25 later devices descend from it.

Decided: Jan 20, 1995
Review: 184 days
Class: Class II
Product code: KGI
Recalls: None
Predicates: 0

25 later devices descend from it, 5 citing it directly.

This deviceK943505 Hologic QDR-3000 X-Ray Bone DensitometerHologic, Inc. · 1995
Descendant · cites it directly · 19 of its ownK023398 Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500…Hologic, Inc. · 2002 · Recalled
Descendant · 2 generations on · 13 of its ownK061561 Hip Structural Analysis Software Option for the Hologic QDR X-Ray…Hologic, Inc. · 2006
Descendant · cites it directly · 11 of its ownK002113 Ctxa Hip; Ctxa; QCT Pro Ctxa HipMindways Software, Inc. · 2001
Descendant · 3 generations on · 7 of its ownK072664 GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008
Descendant · 2 generations on · 6 of its ownK082402 Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2001high 3 (2003) · low 0 (2005)2026

Most influential descendants

Showing 5 of 25 · See all

K023398Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, DiscoveryHologic, Inc. · 2002 · cites it directly19descendants
K061561Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone DensitometersHologic, Inc. · 2006 · 2 generations on13descendants
K002113Ctxa Hip; Ctxa; QCT Pro Ctxa HipMindways Software, Inc. · 2001 · cites it directly11descendants
K072664GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008 · 3 generations on7descendants
K082402Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008 · 2 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K943505	Hologic QDR-3000 X-Ray Bone Densitometer	Hologic, Inc.	1995	—
+1	K023398	Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery	Hologic, Inc.	2002	1
+2	K061561	Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone…	Hologic, Inc.	2006	—
+1	K002113	Ctxa Hip; Ctxa; QCT Pro Ctxa Hip	Mindways Software, Inc.	2001	—
+3	K072664	GE Lunar Femur Strength Software	Ge Medical Systems Ultrasound and Primary Care Dia	2008	—
+2	K082402	Osdx Hip BMD System	Imaging Therapeutics, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2003	3	0
2004	2	0
2006	1	0
2008	3	0
2012	2	0
2014	2	0
2016	2	0
2018	1	0
2019	1	0
2022	1	0
2023	1	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K943505, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KGI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KGI device

#1 K252718 Lunar Astrascore 13.3 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (25)

See all 25

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K023398	Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery	Hologic, Inc.	2002	19
K002113	Ctxa Hip; Ctxa; QCT Pro Ctxa Hip	Mindways Software, Inc.	2001	11
K033224	Hologic QDR Explorer X-Ray Bone Densitometer, Model Explorer	Hologic, Inc.	2003	1
K041266	Pediatric Reference Database	Hologic, Inc.	2004	0
K031991	Dxaview Spine and Hip, Model QCT-3D Plus	Image Analysis, Inc.	2003	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K023398 (Hologic, Inc., 2002) has gone furthest, with 19 descendants of its own.

How does its category compare?

All KGI devices

KGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGI

3in 2025

2007high 5 (2008) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KGI

156in 2025

2007high 173 (2008) · low 142 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KGI

1in 2016

2007high 9 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KGI

8in 2025

2007high 16 (2017) · low 0 (2007)2025

MAUDE reports naming product code KGI, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	0
2008	5	173	6	2
2009	1	—	9	3
2010	0	—	0	0
2011	2	—	1	5
2012	5	142	0	1
2013	1	—	0	1
2014	2	—	0	2
2015	0	—	0	0
2016	2	—	1	1
2017	0	—	0	16
2018	1	—	0	6
2019	1	—	0	0
2020	0	—	0	2
2021	0	—	0	1
2022	2	—	0	1
2023	1	—	0	2
2024	0	—	0	2
2025	3	156	0	8
2026	2	—	0	—

https://510kreport.com/device/K943505 · printed Nov 6, 2026

Cite this page

510(k) Report. “K943505: Hologic QDR-3000 X-Ray Bone Densitometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943505

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026