510(k) · Cleared
ClearedPixi Bone Densitometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lunar Corp. · KGI Densitometer, Bone
Cleared on Apr 16, 1997 as substantially equivalent to K891582 (Osteon, Inc., 1989) after an 85-day review. Its family tree reaches back 1 generation to 1989. 3 later devices descend from it.
- Decided
- Apr 16, 1997
- Review
- 85 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K891582 (1989). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK891582 Modified Osteoanalyzer (# SPSHA110/220)Osteon, Inc. · 1989
- This deviceK970224 Pixi Bone DensitometerLunar Corp. · 1997
- Descendant · cites it directly · 0 of its ownK113616 ACCUDXA2Lone Oak Medical Technologies, LLC · 2012
- Descendant · cites it directly · 0 of its ownK033550 DXL CalscanDemetech AB · 2004
- Descendant · cites it directly · 0 of its ownK983724 Orca-DX Bone DensitometerLunar Corp. · 1998
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891582 | Modified Osteoanalyzer (# SPSHA110/220) | Osteon, Inc. | 1989 | — |
| 0 (this device) | K970224 | Pixi Bone Densitometer | Lunar Corp. | 1997 | — |
| +1 | K113616 | ACCUDXA2 | Lone Oak Medical Technologies, LLC | 2012 | — |
| +1 | K033550 | DXL Calscan | Demetech AB | 2004 | — |
| +1 | K983724 | Orca-DX Bone Densitometer | Lunar Corp. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2012 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K891582 | Modified Osteoanalyzer (# SPSHA110/220)Summary page 1…/Trade Name: PIXI Bone Densitometer Common Name: Bone Densitometer Classification Name: Bone Densitometer 21CFR 892.1170 Predicate Device: Osteon Osteoanalyzer 510 (k) K891582 Norland pDEXA 510 (k) K93199¢ 10.1 DESCRIPTION OF THE DEVICE: The PIXI Bone provides an estimation of Bone Mineral Density (BM… | 1989 |
| Kept off the family tree | K931996 | FDA’s K931996 is Model Pdexa Bone Densitometer Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1995 |
What descends from it? (3)
3 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 | — |
https://510kreport.com/device/K970224 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970224: Pixi Bone Densitometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970224
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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