# K961011: DTX-200 Bone Densitometer

- Pathway: 510(k) (Traditional)
- Applicant: Shotwell & Carr, Inc.
- Decided: Jul 5, 1996 after 114 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
- (no number) Hologic, Inc. model QDR-1000/W bone densitometer: named in the summary without a submission number

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

Source page: https://510kreport.com/device/K961011
Methodology: https://510kreport.com/methodology