510(k) · Cleared
Recalled · 2011XR 46 Dxa (Central) Bone Densitometer, Model XR 46
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Norland Medical Systems, Inc. · KGI Densitometer, Bone
Cleared on Nov 22, 1999 as substantially equivalent to K881865 (Norland Corp., 1989) and 3 other predicates after a 152-day review. Its family tree reaches back 2 generations to 1995. It has been recalled once.
- Decided
- Nov 22, 1999
- Review
- 152 days
- Class
- Class II
- Product code
- KGI
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K935454 (1995). 6 ancestors in all, the oldest K881865 (1989). No later device cites it as a predicate yet.
- Root · 2 generations backK935454 DPX Tissue Quantification OutputLunar Corp. · 1995
- 1 generation backK973459 Norland Body Composition Option for Norland Dexa Bone DensitometersNorland Corp. · 1998
- This deviceK992125 XR 46 Dxa (Central) Bone Densitometer, Model XR 46Norland Medical Systems, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935454 | DPX Tissue Quantification Output | Lunar Corp. | 1995 | — |
| −1 | K973459 | Norland Body Composition Option for Norland Dexa Bone Densitometers | Norland Corp. | 1998 | — |
| 0 (this device) | K992125 | XR 46 Dxa (Central) Bone Densitometer, Model XR 46 | Norland Medical Systems, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
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
What was it cleared against? (4)
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 | Decided |
|---|---|---|---|
| * | K881865 | Norland Model XR-26 X-Ray Bone DensitometerSummary page 1…Modet XR 46 DXA Bone Densitometer DXA table (central) bone densitometer Bone densitometer, (21 CFR 892.1170), product code 90KGI; Class II XR 26 DXA bone densitometer (K881865), Body Composition Assessment (K973459), Reference Population (K964307), and Fracture Risk Assessment for Norland bone densito… | 1989 |
| * | K973459 | Norland Body Composition Option for Norland Dexa Bone DensitometersSummary page 1…able (central) bone densitometer Bone densitometer, (21 CFR 892.1170), product code 90KGI; Class II XR 26 DXA bone densitometer (K881865), Body Composition Assessment (K973459), Reference Population (K964307), and Fracture Risk Assessment for Norland bone densitometers (K980569). The XR 46 is a full f… | 1998 |
| * | K964307 | Expanded Reference Values for DPX Bon DensitometersSummary page 1…Bone densitometer, (21 CFR 892.1170), product code 90KGI; Class II XR 26 DXA bone densitometer (K881865), Body Composition Assessment (K973459), Reference Population (K964307), and Fracture Risk Assessment for Norland bone densitometers (K980569). The XR 46 is a full featured, pencil beam, DXA, table… | 1997 |
| * | K980569 | Fracture Risk Assessment Capability for Norland X-Ray Bone DensitometersSummary page 1…6 DXA bone densitometer (K881865), Body Composition Assessment (K973459), Reference Population (K964307), and Fracture Risk Assessment for Norland bone densitometers (K980569). The XR 46 is a full featured, pencil beam, DXA, table bone densitometer that scans the Hip, Spine, Forearm, Whole Body, and ot… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 23, 2011 | Not classified | Z-0213-2012 | Software design | 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 Densitometers, could lead to improper… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGI
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGI
156in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGI
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGI
8in 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 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…
Read the full statement (171 words)
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.
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/K992125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992125: XR 46 Dxa (Central) Bone Densitometer, Model XR 46.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992125
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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