# K970224: Pixi Bone Densitometer

- Pathway: 510(k) (Traditional)
- Applicant: Lunar Corp.
- Decided: Apr 16, 1997 after 85 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 K891582 (1989). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891582: Modified Osteoanalyzer (# SPSHA110/220), Osteon, Inc. (1989) Summary page 1.

## Cited in the summary but kept off the family tree
- K931996: Model Pdexa Bone Densitometer, Norland Corp. (1995). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K113616: ACCUDXA2 (2012), 0 descendants of its own
- K033550: DXL Calscan (2004), 0 descendants of its own
- K983724: Orca-DX Bone Densitometer (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K970224
Methodology: https://510kreport.com/methodology