# K992125: XR 46 Dxa (Central) Bone Densitometer, Model XR 46

- Pathway: 510(k) (Traditional)
- Applicant: Norland Medical Systems, Inc.
- Decided: Nov 22, 1999 after 152 days
- Product code: KGI (Densitometer, Bone)
- Device class: 2
- Regulation: 21 CFR 892.1170
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K935454 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881865: Norland Model XR-26 X-Ray Bone Densitometer, Norland Corp. (1989) Summary page 1.
- K973459: Norland Body Composition Option for Norland Dexa Bone Densitometers, Norland Corp. (1998) Summary page 1.
- K964307: Expanded Reference Values for DPX Bon Densitometers, Lunar Corp. (1997) Summary page 1.
- K980569: Fracture Risk Assessment Capability for Norland X-Ray Bone Densitometers, Norland Corp. (1998) Summary page 1.

## Recalls of this device
- Sep 23, 2011 · Not classified · Z-0213-2012: The DICOM Software, Norland Illuminatus DXA Software with the DICOM Option (Part Number 434A133) version 4.2.0 through 4.3.1, which is installed on the XR-600, XR-800, XR-46 and EXCELL DXA Bone Densit

## Indications for use
The XR 46 performs DXA scans of the AP Spine, Hip, Forearm, Lateral Spine, and Whole Body, as well as other user selectable sites. It provides, BMD (g/cm2), Area (cm2), and BMC (g) values. It compares these values to gelfier and ethnic matched reference populations and provides T-Score and % Young Reference, Z-Score and % age matched, and long term and short term change values. This includes sBMD (mg/cm2). The XR 46 performs soft tissue assessment and provides lean mass, fat mass, percent fat, and total soft tissue values for all scan sites, including Whole Body. The XR 46 includes a Report Writer that allows the operator to customize the appearance of their reports and to automate the tedious part of the report. It also allows the user to enter ranges of patient values and the specific statements they want to be printed on their reports for each of these ranges. The bone density measurements from the XR 46 can be used as an aid to physicians in determining fracture risk.

Source page: https://510kreport.com/device/K992125
Methodology: https://510kreport.com/methodology