# K973459: Norland Body Composition Option for Norland Dexa Bone Densitometers

- Pathway: 510(k) (Traditional)
- Applicant: Norland Corp.
- Decided: Feb 13, 1998 after 154 days
- Product code: KGI (Densitometer, Bone)
- Device class: 2
- Regulation: 21 CFR 892.1170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K935454 (1995). 1 ancestor in all.
12 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935454: DPX Tissue Quantification Output, Lunar Corp. (1995) Summary page 1.

## Most influential descendants
- K071570: GE Lunar Body Composition Software (2007), 10 descendants of its own
- K113286: Encore 14 Software Release for the GE Lunar Dxa Bone Densitometers (2012), 5 descendants of its own
- K161682: GE Lunar DXA Bone Densitometers with enCORE version 17 (2016), 4 descendants of its own
- K191112: GEHC DXA Bone Densitometers with enCORE version 18 (2019), 2 descendants of its own
- K103730: GE Lunar Visceral Fat Software (2011), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K973459
Methodology: https://510kreport.com/methodology