# K121716: TBS Insight

- Pathway: 510(k) (Traditional)
- Applicant: Medimaps Group SA
- Decided: Oct 5, 2012 after 116 days
- Product code: KGI (Densitometer, Bone)
- Device class: 2
- Regulation: 21 CFR 892.1170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K890121 (1990). 21 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082402: Osdx Hip BMD System, Imaging Therapeutics, Inc. (2008) Summary page 2.

## Most influential descendants
- K152299: TBS iNsight (2016), 4 descendants of its own
- K191112: GEHC DXA Bone Densitometers with enCORE version 18 (2019), 2 descendants of its own
- K252718: Lunar Astra (2026), 0 descendants of its own
- K251022: 3D-Shaper (2025), 0 descendants of its own
- K243218: TBS iNsight (V4) (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K121716
Methodology: https://510kreport.com/methodology