# K021331: Dexacare G4

- Pathway: 510(k) (Special)
- Applicant: Osteometer Meditech, Inc.
- Decided: May 21, 2002 after 25 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 K964562 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964562: DTX-200 Bone Densitometer, Osteometer Meditech A/S (1997) Summary page 1.

## Indications for use
To estimate bone mineral content (BMC, grams) and bone mineral density (BMD, grams/cmz).

Source page: https://510kreport.com/device/K021331
Methodology: https://510kreport.com/methodology