# K983028: Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Nov 13, 1998 after 74 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 K973104 (1998). 1 ancestor in all.
25 later devices descend from it; 4 cite 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)
- K973104: Norland Model Pdexa Bone Densitometer, Norland Corp. (1998) Summary page 1.
- (no number) NORLAND-CAMERON Bone Mineral Analyzer, Model 178, Preamendment device: 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
- K082317: GE Lunar Frax 10-Year Fracture Risk Software Option (2008), 7 descendants of its own
- K082402: Osdx Hip BMD System (2008), 6 descendants of its own

## Indications for use
The intended use of the Hologic Fracture Risk Option includes an added feature of estimation of Fracture Risk from bone mineral density (BMD) using the Hologic QDR X-Ray Bone Densitometers.

Source page: https://510kreport.com/device/K983028
Methodology: https://510kreport.com/methodology