510(k) · Cleared
Recalled · Class II · 2025TBS 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 Apr 29, 2016 as substantially equivalent to K121716 (Medimaps Group SA, 2012) and 1 other predicate after a 260-day review. Its family tree reaches back 6 generations to 1990. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 29, 2016
- Review
- 260 days
- Class
- Class II
- Product code
- KGI
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 6 generations to K890121 (1990). 24 ancestors in all, the oldest K883280 (1988). 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK890121 Modified DPX Bone DensitometerLunar · 1990
- 5 generations backK961007 Expert Spine Morphotietry ReferenceLunar Corp. · 1996
- 4 generations backK011917 Advanced Hip Assessment SoftwareGe Lunar Corp. · 2001
- 3 generations backK061561 Hip Structural Analysis Software Option for the Hologic QDR X-Ray…Hologic, Inc. · 2006
- 2 generations backK082402 Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008
- 1 generation backK121716 TBS InsightMedimaps Group SA · 2012
- This deviceK152299 TBS iNsightMedimaps Group SA · 2016
- Descendant · cites it directly · 2 of its ownK191112 GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK252718 Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK251022 3D-Shaper3D-Shaper Medical S.L · 2025
- Descendant · cites it directly · 0 of its ownK243218 TBS iNsight (V4)Medimaps Group SA · 2025
Most influential descendants
Showing 4 of 4 · See all- K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · cites it directly2descendants
- K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026 · 2 generations on0descendants
- K2510223D-Shaper3D-Shaper Medical S.L · 2025 · 2 generations on0descendants
- K243218TBS iNsight (V4)Medimaps Group SA · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K890121 | Modified DPX Bone Densitometer | Lunar | 1990 | — |
| −5 | K961007 | Expert Spine Morphotietry Reference | Lunar Corp. | 1996 | — |
| −4 | K011917 | Advanced Hip Assessment Software | Ge Lunar Corp. | 2001 | — |
| −3 | K061561 | Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone… | Hologic, Inc. | 2006 | — |
| −2 | K082402 | Osdx Hip BMD System | Imaging Therapeutics, Inc. | 2008 | — |
| −1 | K121716 | TBS Insight | Medimaps Group SA | 2012 | — |
| 0 (this device) | K152299 | TBS iNsight | Medimaps Group SA | 2016 | — |
| +1 | K191112 | GEHC DXA Bone Densitometers with enCORE version 18 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2019 | 1 |
| +2 | K252718 | Lunar Astra | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026 | — |
| +2 | K251022 | 3D-Shaper | 3D-Shaper Medical S.L | 2025 | — |
| +1 | 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 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K121716 | TBS InsightSummary page 6…icate devices provide an assessment of the risk for fracture of patients based on DXA scans. This predicate devices are Med-Imaps TBS iNsight, cleared under K121716, and GE Lunar FRAX™ 10-year Fracture Risk software option, cleared under K082317. SUBSTANTIAL EQUIVALENCE Th… | 2012 |
| * | K082317 | GE Lunar Frax 10-Year Fracture Risk Software OptionSummary page 6…DXA scans. This predicate devices are Med-Imaps TBS iNsight, cleared under K121716, and GE Lunar FRAX™ 10-year Fracture Risk software option, cleared under K082317. SUBSTANTIAL EQUIVALENCE The following table provides a more detailed substantial equivalence discussion :… | 2008 |
What descends from it? (4)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 3, 2025 | Class II | Z-1250-2025 | Software Design Change | Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines. |
| Oct 3, 2016 | Class II | Z-0369-2017 | Under Investigation by firm | The FRAX adjusted for TBS values are not correct when: The FRAX feature is activated in TBS iNsight; and TBS has been computed from a spine scan where some vertebrae were excluded. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 24 ancestors has a recall of any class.
- Of its descendants, K191112 (GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, 2019) has gone furthest, with 2 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. 2016, 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?
TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age-matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. TBS iNsight provides as an option an assessment of 10-year fracture…
Read the full statement (273 words)
TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age-matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture.
TBS iNsight provides as an option an assessment of 10-year fracture risk. It provides an estimate of 10-year probability of hip fracture and 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate is based on the WHO’s FRAX® Fracture Risk Assessment Tool, after adjustment for the TBS. The tool has been validated for Caucasian and Asian men and post-menopausal women between 40 and 90 years old.
TBS provides information independent of BMD value; it is used as a complement to the data obtained from the DXA analysis and the clinical examination (questioning by the clinician about patient history, bioassay of bone resorption markers...).
The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk.
The TBS score can assist the health care professional 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152299 · printed Nov 5, 2026
Cite this page
510(k) Report. “K152299: TBS iNsight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152299
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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