510(k) · Cleared
ClearedTBS Insight
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medimaps Group SA · KGI Densitometer, Bone
Cleared on Oct 5, 2012 as substantially equivalent to K082402 (Imaging Therapeutics, Inc., 2008) after a 116-day review. Its family tree reaches back 5 generations to 1990. 5 later devices descend from it.
- Decided
- Oct 5, 2012
- Review
- 116 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K890121 (1990). 21 ancestors in all, the oldest K883280 (1988). 5 later devices descend 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 backK082402 Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008
- This deviceK121716 TBS InsightMedimaps Group SA · 2012
- Descendant · cites it directly · 4 of its ownK152299 TBS iNsightMedimaps Group SA · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK191112 GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · Recalled
- Descendant · 3 generations on · 0 of its ownK252718 Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK251022 3D-Shaper3D-Shaper Medical S.L · 2025
- Descendant · 2 generations on · 0 of its ownK243218 TBS iNsight (V4)Medimaps Group SA · 2025
Most influential descendants
Showing 5 of 5 · See all- K152299TBS iNsightMedimaps Group SA · 2016 · cites it directly4descendants
- K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · 2 generations on2descendants
- K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026 · 3 generations on0descendants
- K2510223D-Shaper3D-Shaper Medical S.L · 2025 · 3 generations on0descendants
- K243218TBS iNsight (V4)Medimaps Group SA · 2025 · 2 generations on0descendants
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 | K082402 | Osdx Hip BMD System | Imaging Therapeutics, Inc. | 2008 | — |
| 0 (this device) | K121716 | TBS Insight | Medimaps Group SA | 2012 | — |
| +1 | K152299 | TBS iNsight | Medimaps Group SA | 2016 | 2 |
| +2 | K191112 | GEHC DXA Bone Densitometers with enCORE version 18 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2019 | 1 |
| +3 | K252718 | Lunar Astra | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026 | — |
| +3 | K251022 | 3D-Shaper | 3D-Shaper Medical S.L | 2025 | — |
| +2 | K243218 | TBS iNsight (V4) | Medimaps Group SA | 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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K082402 | Osdx Hip BMD SystemSummary page 2…e of the bone strength and a comparison to a normative data cohort for interpretation. This predicate device is Imaging Therapeutics Os~x Hip BMVD System, cleared under K082402. SUBSTANTIAL EQUIVALENCE The following table provides a more detailed substantial equivalence discussion… | 2008 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152299 | TBS iNsight | 2016 | 4 |
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 21 ancestors has a recall of any class.
- Of its descendants, K152299 (Medimaps Group SA, 2016) has gone furthest, with 4 descendants of its own.
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?
The Med-Imaps TBS iNsight is a software provided for use as a complement to a DEXA analysis. It computes the antero-posterior spine QEXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age-matched controls. The TES is derived from the texture of the DEXA image and has been shown to be related to bone microarchitecture and fracture risk. This data provides information independent of BMD value; it is…
Read the full statement (169 words)
The Med-Imaps TBS iNsight is a software provided for use as a complement to a DEXA analysis. It computes the antero-posterior spine QEXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age-matched controls. The TES is derived from the texture of the DEXA image and has been shown to be related to bone microarchitecture and fracture risk. This data provides information independent of BMD value; it is used as a complement to the data obtained from the DEXA analysis and the clinical examination (questioning by the clinician about patient history, bioassay of bone resorption markers ...).
The TBS score can assist the health care professional in assessment of fracture risk and in monitoring the effect of treatments on patients across time.
Overall fracture risk will depend on many additional factors that should be considered before making diagnostic or therapeutic recommendations. The software does not diagnose disease, or recommend treatment regimens. Only the health care professional can make these judgments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121716: TBS Insight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121716
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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