# K113616: ACCUDXA2

- Pathway: 510(k) (Traditional)
- Applicant: Lone Oak Medical Technologies, LLC
- Decided: Apr 27, 2012 after 142 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: 2 generations back to K891582 (1989). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971735: Accudexa Bone Densitometer, Schick Technologies, Inc. (1997) Summary page 3.
- K981124: Accudexa Bone Densitometer, Schick Technologies, Inc. (1998) Summary page 1.
- K001429: Modification to Accudexa Bone Densitometer, Schick Technologies, Inc. (2000) Summary page 3.
- K000162: Metriscan Bone Density System, Alara, Inc. (2000) Summary page 1.
- K970224: Pixi Bone Densitometer, Lunar Corp. (1997) Summary page 1.

## Indications for use
The Accudxa 2 is a dual-energy x-ray (DXA) device indicated for use in estimating the bone density of the middle finger of the non-dominant hand (BMVD). This BMD value is a relative indicator of bone density elsewhere in the body. Accudxa 2 BMD estimates, t-score and z-score can be used as an aid to the physician in determining fracture risk and for monitoring changes in bone mass over time.

Source page: https://510kreport.com/device/K113616
Methodology: https://510kreport.com/methodology