510(k) · Cleared

Cleared

Norland Body Composition Option for Norland Dexa Bone Densitometers

K973459510(k) TraditionalCleared Feb 13, 1998154-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 Feb 13, 1998 as substantially equivalent to K935454 (Lunar Corp., 1995) after a 154-day review. Its family tree reaches back 1 generation to 1995. 12 later devices descend from it.

Decided: Feb 13, 1998
Review: 154 days
Class: Class II
Product code: KGI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K935454 (1995). 12 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK935454 DPX Tissue Quantification OutputLunar Corp. · 1995
This deviceK973459 Norland Body Composition Option for Norland Dexa Bone DensitometersNorland Corp. · 1998
Descendant · cites it directly · 10 of its ownK071570 GE Lunar Body Composition SoftwareGe Medical Systems Lunar · 2007
Descendant · 2 generations on · 5 of its ownK113286 Encore 14 Software Release for the GE Lunar Dxa Bone DensitometersGe Medical Systems Lunar · 2012
Descendant · 2 generations on · 4 of its ownK161682 GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016 · Recalled
Descendant · 3 generations on · 2 of its ownK191112 GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · Recalled
Descendant · 2 generations on · 1 of its ownK103730 GE Lunar Visceral Fat SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2011

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

1999high 2 (2011) · low 0 (2000)2026

Most influential descendants

Showing 5 of 12 · See all

K071570GE Lunar Body Composition SoftwareGe Medical Systems Lunar · 2007 · cites it directly10descendants
K113286Encore 14 Software Release for the GE Lunar Dxa Bone DensitometersGe Medical Systems Lunar · 2012 · 2 generations on5descendants
K161682GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016 · 2 generations on4descendants
K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · 3 generations on2descendants
K103730GE Lunar Visceral Fat SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2011 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K935454	DPX Tissue Quantification Output	Lunar Corp.	1995	—
0 (this device)	K973459	Norland Body Composition Option for Norland Dexa Bone Densitometers	Norland Corp.	1998	—
+1	K071570	GE Lunar Body Composition Software	Ge Medical Systems Lunar	2007	—
+2	K113286	Encore 14 Software Release for the GE Lunar Dxa Bone Densitometers	Ge Medical Systems Lunar	2012	—
+2	K161682	GE Lunar DXA Bone Densitometers with enCORE version 17	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	2016	1
+3	K191112	GEHC DXA Bone Densitometers with enCORE version 18	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	2019	1
+2	K103730	GE Lunar Visceral Fat Software	Ge Medical Systems Ultrasound and Primary Care Dia	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2007	1	0
2009	1	0
2011	2	0
2012	2	0
2016	1	0
2018	1	0
2019	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K973459, 1995–2026Source: 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? (1)

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
*	K935454	DPX Tissue Quantification Output Summary page 1 …on Option for DEXA bone densitometers Bone densitometer, (21 CFR 892.1170), product code 90KGI; Class Il Lunar Total Body Software Option for the DPX bone densitometer (K935454) The Norland Body Composition Option (body composition) is used with Norland DEXA bone densitometers to estimate the relative am…	Lunar Corp.	1995	—

Also cleared against K935454: 2 other devices →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K071570	GE Lunar Body Composition Software	Ge Medical Systems Lunar	2007	10
K992125	XR 46 Dxa (Central) Bone Densitometer, Model XR 46	Norland Medical Systems, Inc.	1999	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?

Its one ancestor has no recall.
Of its descendants, K071570 (Ge Medical Systems Lunar, 2007) has gone furthest, with 10 descendants of its own.
2 other devices also cite its predicate K935454.

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 Norland Body Composition Option (body composition) assesses the non-bone tissue determined during the bone density scans performed by Norland DEXA bone densitometers, and estimates soft tissue mass, fat mass, lean mass, total soft tissue mass, % fat, TBMC/LBM (Total Bone Mineral Content / Lean Body Mass), and Siri and Brozek equation equivalent values. These body composition estimates are useful to health care professionals in their management of…

Read the full statement (152 words)

The Norland Body Composition Option (body composition) assesses the non-bone

tissue determined during the bone density scans performed by Norland DEXA

bone densitometers, and estimates soft tissue mass, fat mass, lean mass, total soft

tissue mass, % fat, TBMC/LBM (Total Bone Mineral Content / Lean Body

Mass), and Siri and Brozek equation equivalent values.

These body composition estimates are useful to health care professionals in their

management of diseases/conditions where the disease/condition itself, or its

treatment, can affect the relative amounts of patient fat and lean tissue. The

Norland Body Composition Option does not diagnose disease, or recommend

treatment regimens, or quantify treatment effectiveness. Only the health care

professional can make these judgments. Some of the diseases/conditions for which

lean and fat tissue estimates are useful are chronic renal failure, Anorexia

Nervosa, excessive obesity, AIDS/HIV, and Cystic Fibrosis. Body composition is

also a convenient altemative to hydrostatic weighing and skin fold measurements.

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/K973459 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973459: Norland Body Composition Option for Norland Dexa Bone Densitometers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973459

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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