510(k) · Cleared
ClearedDxaview Spine and Hip, Model QCT-3D Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Image Analysis, Inc. · KGI Densitometer, Bone
Cleared on Jul 30, 2003 as substantially equivalent to K992246 (Image Analysis, Inc., 1999) and 3 other predicates after a 33-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Jul 30, 2003
- Review
- 33 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K883280 (1988). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883280 | Hologic QDR-1000 X-Ray Bone Densitometer/Modified | Hologic, Inc. | 1988 | — |
| −1 | K002113 | Ctxa Hip; Ctxa; QCT Pro Ctxa Hip | Mindways Software, Inc. | 2001 | — |
| 0 (this device) | K031991 | Dxaview Spine and Hip, Model QCT-3D Plus | Image Analysis, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 2 | 0 |
| 1999 | 1 | 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 |
|---|---|---|---|
| * | K992246 | QCT Bone Mineral Analysis SoftwareSummary page 1…ion Name: Bone Densitometer, 21 CFR 892.1170, Class 11 Predicate Devices: K992246: QCT Bone Mineral Analysis Software Intended Use: QCT Bone Densitometry to estimate bone density and… | 1999 |
| * | K941127 | QCT-Bone Mineral Analysis SoftwareSummary page 1…imate bone density and bone density changes, for monitoring therapy, and to estimate fracture risk. K941127: OCT Bone Mineral Analysis Software Intended Use: Estimation of bone density in the spine.… | 1995 |
| * | K943505 | Hologic QDR-3000 X-Ray Bone DensitometerSummary page 1…K941127: OCT Bone Mineral Analysis Software Intended Use: Estimation of bone density in the spine. K943505: Hologic QDR 3000 X-Ray Bone Densitometer Intended Use: Estimate bone mineral density and bone mineral… | 1995 |
| * | K002113 | Ctxa Hip; Ctxa; QCT Pro Ctxa HipSummary page 1…r Intended Use: Estimate bone mineral density and bone mineral content at various anatomical sites. K002113: CTXAHip Intended Use: Estimate bone density and bone mineral content in the hip. C… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 13.2 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K992246.
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 DXAVIEW™ Hip and Spine bone densitometry Options are intended to provide estimates of bone mineral density (BMD) and bone mineral content (BMC) in the proximal femur and spine. Young normal reference data taken from caucasian populations can be used to calculate T-Scores. Age matched normal reference data are used to calculate Z-Scores. The BMD results, along with the T- and Z-Scores, can be used by physicians in their determination of fracture risk and therapy effectiveness.
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/K031991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031991: Dxaview Spine and Hip, Model QCT-3D Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031991
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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