# K891582: Modified Osteoanalyzer (# SPSHA110/220)

- Pathway: 510(k) (Traditional)
- Applicant: Osteon, Inc.
- Decided: Sep 12, 1989 after 176 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.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K970224: Pixi Bone Densitometer (1997), 3 descendants of its own
- 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
- K972882: Apollo (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K891582
Methodology: https://510kreport.com/methodology