510(k) · Cleared
ClearedVirtuost
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O.N. Diagnostics · KGI Densitometer, Bone
Cleared on Sep 13, 2012 as substantially equivalent to K983028 (Hologic, Inc., 1998) and 3 other predicates after a 269-day review. Its family tree reaches back 5 generations to 1990. 1 later device descends from it.
- Decided
- Sep 13, 2012
- Review
- 269 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K890121 (1990). 20 ancestors in all, the oldest K883280 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK890121 Modified DPX Bone DensitometerLunar · 1990
- 4 generations backK961007 Expert Spine Morphotietry ReferenceLunar Corp. · 1996
- 3 generations backK011917 Advanced Hip Assessment SoftwareGe Lunar Corp. · 2001
- 2 generations backK061561 Hip Structural Analysis Software Option for the Hologic QDR X-Ray…Hologic, Inc. · 2006
- 1 generation backK072664 GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008
- This deviceK113725 VirtuostO.N. Diagnostics · 2012
- Descendant · cites it directly · 0 of its ownK220402 VirtuOstO.N. Diagnostics · 2023
Most influential descendants
Showing 1 of 1 · See all- K220402VirtuOstO.N. Diagnostics · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K890121 | Modified DPX Bone Densitometer | Lunar | 1990 | — |
| −4 | K961007 | Expert Spine Morphotietry Reference | Lunar Corp. | 1996 | — |
| −3 | K011917 | Advanced Hip Assessment Software | Ge Lunar Corp. | 2001 | — |
| −2 | K061561 | Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone… | Hologic, Inc. | 2006 | — |
| −1 | K072664 | GE Lunar Femur Strength Software | Ge Medical Systems Ultrasound and Primary Care Dia | 2008 | — |
| 0 (this device) | K113725 | Virtuost | O.N. Diagnostics | 2012 | — |
| +1 | K220402 | VirtuOst | O.N. Diagnostics | 2023 | — |
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 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K983028 | Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000, QDR1500…Summary page 5…ification Name: Bone Densitometer Regulation Number: 21 CFR 892.1170 Device Classification: Class 11 3) Identification of Predicate Devices K983028: Hologic QDR X-Ray Bone Densitometers with an added feature of Estimation of Fracture Risk from BMD K894854: QCT Bone Mine… | 1998 |
| * | K894854 | QCT Bone Mineral Density Analysis SoftwareSummary page 5…Class 11 3) Identification of Predicate Devices K983028: Hologic QDR X-Ray Bone Densitometers with an added feature of Estimation of Fracture Risk from BMD K894854: QCT Bone Mineral Density Analysis Software K072664: GE Lunar Femur Strength Software Option K992246: image Analysis QCT… | 1989 |
| * | K072664 | GE Lunar Femur Strength SoftwareSummary page 5…983028: Hologic QDR X-Ray Bone Densitometers with an added feature of Estimation of Fracture Risk from BMD K894854: QCT Bone Mineral Density Analysis Software K072664: GE Lunar Femur Strength Software Option K992246: image Analysis QCT Bone Mineral Analysis (BMA) Software 4) Device Descrip… | 2008 |
| * | K992246 | QCT Bone Mineral Analysis SoftwareSummary page 5…added feature of Estimation of Fracture Risk from BMD K894854: QCT Bone Mineral Density Analysis Software K072664: GE Lunar Femur Strength Software Option K992246: image Analysis QCT Bone Mineral Analysis (BMA) Software 4) Device Description VirtuOst is a stand-alone software package t… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220402 | VirtuOst | 2023 | 0 |
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 22 years and passes through 6 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, K220402 (O.N. Diagnostics, 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K983028.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
VirtuOst uses data from computed tomography scans to estimate bone mineral density,
bone strength, and a load-to-strength ratio. This information can be used by a
physician to assess fracture risk, identify ostebporosis, and monitor therapy. For
pediatric patients, VirtuOst provides these estimates without any classifications and
should be used only when the benefit of obtaining these estimates outweighs the risk
of radiation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113725 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113725: Virtuost.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113725
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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