# K971735: Accudexa Bone Densitometer

- Pathway: 510(k) (Traditional)
- Applicant: Schick Technologies, Inc.
- Decided: Dec 2, 1997 after 204 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 K913321 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913321: Hologic QDR-2000 X-Ray Bone Densitometer, Hologic, Inc. (1991) Summary page 1.
- K933455: Computed Oral Radiology System, Schick Technologies, Inc. (1994) Summary page 1.
- (no number) Osteogram Radiographic Absorptiometry (RA) device: named in the summary without a submission number

## Most influential descendants
- K113616: ACCUDXA2 (2012), 0 descendants of its own

## Indications for use
The accuDEXA is a dual-energy x-ray device indicated for use in estimating the bone density of the middle finger of the non-dominant hand (BMD). This BMD value is a relative indicator of bone density elsewhere in the body.

Source page: https://510kreport.com/device/K971735
Methodology: https://510kreport.com/methodology