# K002113: Ctxa Hip; Ctxa; QCT Pro Ctxa Hip

- Pathway: 510(k) (Traditional)
- Applicant: Mindways Software, Inc.
- Decided: Dec 4, 2001 after 545 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: 1 generation back to K883280 (1988). 3 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894854: QCT Bone Mineral Density Analysis Software, Image Enhancements (1989) Summary page 1.
- K883280: Hologic QDR-1000 X-Ray Bone Densitometer/Modified, Hologic, Inc. (1988) Summary page 1.
- K943505: Hologic QDR-3000 X-Ray Bone Densitometer, Hologic, Inc. (1995) Summary page 1.
- (no number) Norland Model 178 Bone Densitometer: named in the summary without a submission number

## Most influential descendants
- K082402: Osdx Hip BMD System (2008), 6 descendants of its own
- 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
- K030330: Ctxa Hip Extended Reference Data (2003), 1 descendant of its own

## Indications for use
The CTXA Hip Bone Mineral Densitometer is intended to estimate bone mineral content (BMC) and bone mineral density (BMD) in the proximal femur. The BMD estimates can be compared with CTXA Hip-derived reference data. T-scores are calculated with respect to CTXA Hip young normal female reference data, and the T-scores can be used by the physician as an aid in determining fracture risk.

Source page: https://510kreport.com/device/K002113
Methodology: https://510kreport.com/methodology