510(k) · Cleared

Cleared

Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W

K983028510(k) TraditionalCleared Nov 13, 199874-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 Nov 13, 1998 as substantially equivalent to K973104 (Norland Corp., 1998) after a 74-day review. Its family tree reaches back 1 generation to 1998. 25 later devices descend from it.

Decided: Nov 13, 1998
Review: 74 days
Class: Class II
Product code: KGI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K973104 (1998). 25 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK973104 Norland Model Pdexa Bone DensitometerNorland Corp. · 1998
This deviceK983028 Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500…Hologic, Inc. · 1998
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 · 3 generations on · 7 of its ownK072664 GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008
Descendant · cites it directly · 7 of its ownK082317 GE Lunar Frax 10-Year Fracture Risk Software OptionGeneral Electric Co. · 2008
Descendant · 3 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

2002high 5 (2008) · 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
K072664GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008 · 3 generations on7descendants
K082317GE Lunar Frax 10-Year Fracture Risk Software OptionGeneral Electric Co. · 2008 · cites it directly7descendants
K082402Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008 · 3 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K973104	Norland Model Pdexa Bone Densitometer	Norland Corp.	1998	—
0 (this device)	K983028	Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000…	Hologic, Inc.	1998	—
+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	—
+3	K072664	GE Lunar Femur Strength Software	Ge Medical Systems Ultrasound and Primary Care Dia	2008	—
+1	K082317	GE Lunar Frax 10-Year Fracture Risk Software Option	General Electric Co.	2008	—
+3	K082402	Osdx Hip BMD System	Imaging Therapeutics, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	2	0
2006	1	0
2008	5	0
2009	1	0
2012	2	0
2014	1	0
2016	2	0
2018	1	0
2019	1	0
2021	1	0
2022	2	0
2023	1	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K983028, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K973104	Norland Model Pdexa Bone Densitometer Summary page 1 …meters X-Ray Bone Densitometer NORLAND-CAMERON Bone Mineral Analyzer, Model 178, Preamendment device. Norland model pDEXA Bone Densitometer with Fracture Risk Option. (K973104, FDA clearance Jan 29, 1998) The Hologic QDR X-Ray Bone Densitometers with the added feature of estimation of Fracture Risk from…	Norland Corp.	1998	—
*	—	NORLAND-CAMERON Bone Mineral Analyzer, Model 178, Preamendment device Named without a submission number			—

Also cleared against K973104: 5 other devices →

What descends from it? (25)

See all 25

4 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
K082317	GE Lunar Frax 10-Year Fracture Risk Software Option	General Electric Co.	2008	7
K113725	Virtuost	O.N. Diagnostics	2012	1
K080711	1.10-Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometer, Model QDR…	Hologic, Inc.	2008	1

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?

Its one ancestor has no recall.
Of its descendants, K023398 (Hologic, Inc., 2002) has gone furthest, with 19 descendants of its own.
5 other devices also cite its predicate K973104.

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	—

What is it indicated for?

The intended use of the Hologic Fracture Risk Option includes an added feature of estimation of Fracture Risk from bone mineral density (BMD) using the Hologic QDR X-Ray Bone Densitometers.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K983028 · printed Nov 5, 2026

Cite this page

510(k) Report. “K983028: Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983028

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026