# K082402: Osdx Hip BMD System

- Pathway: 510(k) (Traditional)
- Applicant: Imaging Therapeutics, Inc.
- Decided: Oct 16, 2008 after 57 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: 4 generations back to K890121 (1990). 20 ancestors in all.
6 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)
- K002113: Ctxa Hip; Ctxa; QCT Pro Ctxa Hip, Mindways Software, Inc. (2001) Summary page 2.
- K984178: Pronosco X-Posure System, Torsana Osteoporosis Diagnostics A/S (1999) Summary page 2.
- K061561: Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone Densitometers, Hologic, Inc. (2006) Summary page 2.

## Most influential descendants
- K121716: TBS Insight (2012), 5 descendants of its own
- 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

## Indications for use
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.

Source page: https://510kreport.com/device/K082402
Methodology: https://510kreport.com/methodology