# K963789: DTX-100 Bone Densitometer

- Pathway: 510(k) (Traditional)
- Applicant: Osteometer Meditech A/S
- Decided: Jul 14, 1997 after 297 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Osteometer MediTech A/S model DTX-100 bone densitometer: named in the summary without a submission number

## Indications for use
Estimate bone mineral content (BMC in grams) and bone mineral density (BMD in grams/cm’) in the distal section of the forearm.

Source page: https://510kreport.com/device/K963789
Methodology: https://510kreport.com/methodology