# K964307: Expanded Reference Values for DPX Bon Densitometers

- Pathway: 510(k) (Traditional)
- Applicant: Lunar Corp.
- Decided: Apr 16, 1997 after 169 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K890021: Sterile Polyhesive PBS Dressing, Valleylab, Inc. (1989). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K041266: Pediatric Reference Database (2004), 0 descendants of its own
- K992125: XR 46 Dxa (Central) Bone Densitometer, Model XR 46 (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K964307
Methodology: https://510kreport.com/methodology