# K963363: Hologic QDR Series X-Ray Boe Densitometers

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Nov 22, 1996 after 87 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
No predicates in its family tree.
22 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Hologic QDR Series X-Ray Bone Densitometers with Reference Data: named in the summary without a submission number

## Most influential descendants
- K023398: Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery (2002), 19 descendants of its own
- K061561: Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone Densitometers (2006), 13 descendants of its own
- K072664: GE Lunar Femur Strength Software (2008), 7 descendants of its own
- K082402: Osdx Hip BMD System (2008), 6 descendants of its own
- K121716: TBS Insight (2012), 5 descendants of its own

## Indications for use
The intended use of the NHANES Reference Data Software Option for Hologic QDR Series X-Ray Bone Densitometers is to allow comparisons of a subject’s estimated proximal femur (hip) Bone Mineral Density (BMD, in g/cmz) to reference data for sex and ethnicity matched controls. Published results from the NHANES study (A.C. Looker, et al., Osteoporosis International Vol. 5, pg 389-409, 1995), including male and female proximal femur reference values for African American, Mexican American, and caucasian American subjects are included in this software option.

Source page: https://510kreport.com/device/K963363
Methodology: https://510kreport.com/methodology