510(k) · Cleared
ClearedFracture Risk Assessment Capability for Norland X-Ray Bone Densitometers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Norland Corp. · KGI Densitometer, Bone
Cleared on Jun 12, 1998 as substantially equivalent to K973104 (Norland Corp., 1998) after a 119-day review. Its family tree reaches back 1 generation to 1998. 4 later devices descend from it.
- Decided
- Jun 12, 1998
- Review
- 119 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973104 (1998). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK973104 Norland Model Pdexa Bone DensitometerNorland Corp. · 1998
- This deviceK980569 Fracture Risk Assessment Capability for Norland X-Ray Bone…Norland Corp. · 1998
- Descendant · cites it directly · 0 of its ownK993176 Multi-Racial Reference Population for Pdexa and DiscoveryNorland Medical Systems, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK993337 Apollo Multi-Racial Reference PopulationNorland Medical Systems, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK992125 XR 46 Dxa (Central) Bone Densitometer, Model XR 46Norland Medical Systems, Inc. · 1999 · Recalled
- Descendant · cites it directly · 0 of its ownK983273 XCT 2000 L PQCT Bone DensitometerMedical Systems, Inc. · 1998
Most influential descendants
Showing 4 of 4 · See all- K993176Multi-Racial Reference Population for Pdexa and DiscoveryNorland Medical Systems, Inc. · 2000 · cites it directly0descendants
- K993337Apollo Multi-Racial Reference PopulationNorland Medical Systems, Inc. · 2000 · cites it directly0descendants
- K992125XR 46 Dxa (Central) Bone Densitometer, Model XR 46Norland Medical Systems, Inc. · 1999 · cites it directly0descendants
- K983273XCT 2000 L PQCT Bone DensitometerMedical Systems, Inc. · 1998 · cites it directly0descendants
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) | K980569 | Fracture Risk Assessment Capability for Norland X-Ray Bone Densitometers | Norland Corp. | 1998 | — |
| +1 | K993176 | Multi-Racial Reference Population for Pdexa and Discovery | Norland Medical Systems, Inc. | 2000 | — |
| +1 | K993337 | Apollo Multi-Racial Reference Population | Norland Medical Systems, Inc. | 2000 | — |
| +1 | K992125 | XR 46 Dxa (Central) Bone Densitometer, Model XR 46 | Norland Medical Systems, Inc. | 1999 | 1 |
| +1 | K983273 | XCT 2000 L PQCT Bone Densitometer | Medical Systems, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 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? (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 | Decided |
|---|---|---|---|
| * | K973104 | Norland Model Pdexa Bone DensitometerSummary page 1…acture risk assessment for bone densitometers Bone densitometer, (21 CFR 892.1170), product code 90KGI; Class II Fracture Risk Assessment for pPDEXA™ Bone Densitometer (K973104) Norland Medical Systems, Inc., Fort Atkinson, WI Fracture Risk Assessment for the Norland-Cameron Model 178 Bone Mineral Analyz… | 1998 |
| * | — | Fracture Risk Assessment for the Norland-Cameron Model 178 Bone Mineral Analyzer Named without a submission number |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 bone density estimates from Norland X-Ray Bone Densitometers can be used as an aid to the physician in determining risk of fracture.
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/K980569 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980569: Fracture Risk Assessment Capability for Norland X-Ray 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/K980569
Report an extraction error
Are you the manufacturer?
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