# K061625: AUTOBONE2

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Jun 26, 2006 after 14 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K871859 (1987). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031871: Autobone, Ge Medical Systems Europe (2003) Summary page 1.

## Indications for use
The AutoBone 2 option is a software package that is intended to facilitate segmentation of bony structures and calcifications from abdominal and extremity CT Angiography data.

Source page: https://510kreport.com/device/K061625
Methodology: https://510kreport.com/methodology