510(k) · Cleared
ClearedOsdx Hip BMD System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imaging Therapeutics, Inc. · KGI Densitometer, Bone
Cleared on Oct 16, 2008 as substantially equivalent to K002113 (Mindways Software, Inc., 2001) and 2 other predicates after a 57-day review. Its family tree reaches back 4 generations to 1990. 6 later devices descend from it.
- Decided
- Oct 16, 2008
- Review
- 57 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K890121 (1990). 20 ancestors in all, the oldest K883280 (1988). 6 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK890121 Modified DPX Bone DensitometerLunar · 1990
- 3 generations backK961007 Expert Spine Morphotietry ReferenceLunar Corp. · 1996
- 2 generations backK011917 Advanced Hip Assessment SoftwareGe Lunar Corp. · 2001
- 1 generation backK061561 Hip Structural Analysis Software Option for the Hologic QDR X-Ray…Hologic, Inc. · 2006
- This deviceK082402 Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008
- Descendant · cites it directly · 5 of its ownK121716 TBS InsightMedimaps Group SA · 2012
- Descendant · 2 generations on · 4 of its ownK152299 TBS iNsightMedimaps Group SA · 2016 · Recalled
- Descendant · 3 generations on · 2 of its ownK191112 GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · Recalled
- Descendant · 4 generations on · 0 of its ownK252718 Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026
- Descendant · 4 generations on · 0 of its ownK251022 3D-Shaper3D-Shaper Medical S.L · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K121716TBS InsightMedimaps Group SA · 2012 · cites it directly5descendants
- K152299TBS iNsightMedimaps Group SA · 2016 · 2 generations on4descendants
- K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · 3 generations on2descendants
- K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026 · 4 generations on0descendants
- K2510223D-Shaper3D-Shaper Medical S.L · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K890121 | Modified DPX Bone Densitometer | Lunar | 1990 | — |
| −3 | K961007 | Expert Spine Morphotietry Reference | Lunar Corp. | 1996 | — |
| −2 | K011917 | Advanced Hip Assessment Software | Ge Lunar Corp. | 2001 | — |
| −1 | K061561 | Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone… | Hologic, Inc. | 2006 | — |
| 0 (this device) | K082402 | Osdx Hip BMD System | Imaging Therapeutics, Inc. | 2008 | — |
| +1 | K121716 | TBS Insight | Medimaps Group SA | 2012 | — |
| +2 | K152299 | TBS iNsight | Medimaps Group SA | 2016 | 2 |
| +3 | K191112 | GEHC DXA Bone Densitometers with enCORE version 18 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2019 | 1 |
| +4 | K252718 | Lunar Astra | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026 | — |
| +4 | K251022 | 3D-Shaper | 3D-Shaper Medical S.L | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K002113 | Ctxa Hip; Ctxa; QCT Pro Ctxa HipSummary page 2…to indications for use and technological characteristics. These predicate devices are: Technological Characteristics and Indication for Use * CTXA Hip: K002113 * Pronosco X-Posure System Bone Densitometer: K984178 * Hologic Hip Structural Analysis Software K06156… | 2001 |
| * | K984178 | Pronosco X-Posure SystemSummary page 2…dicate devices are: Technological Characteristics and Indication for Use * CTXA Hip: K002113 * Pronosco X-Posure System Bone Densitometer: K984178 * Hologic Hip Structural Analysis Software K061561 INTENDED USE The OsDx Hip BMD System stand-alone software is i… | 1999 |
| * | K061561 | Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone DensitometersSummary page 2…dication for Use * CTXA Hip: K002113 * Pronosco X-Posure System Bone Densitometer: K984178 * Hologic Hip Structural Analysis Software K061561 INTENDED USE The OsDx Hip BMD System stand-alone software is intended to provide an estimate of the bone mineral density (BMD)… | 2006 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121716 | TBS Insight | 2012 | 5 |
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 18 years and passes through 5 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K121716 (Medimaps Group SA, 2012) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K002113.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 OsDx Hip BMD System stand-alone software is intended to provide an estimate of the bone mineral density (BMD) of the proximal femur using digital antero-posterior hip or pelvis radiographic images. This information may be used by the physician in the assessment of fracture risk in conjunction with the World Health Organization ("WHO") criteria and to compare the derived BMD estimate with reference populations of young (20 - 39) and age matched normals to compute T-scores and Z-scores respectively.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082402: Osdx Hip BMD System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082402
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