# K033550: DXL Calscan

- Pathway: 510(k) (Traditional)
- Applicant: Demetech AB
- Decided: May 5, 2004 after 175 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970224: Pixi Bone Densitometer, Lunar Corp. (1997) Summary page 2.
- K983262: Fracture Risk Assessment Option for Pixi Bone Densitometers, Lunar Corp. (1998) Summary page 2.
- K964562: DTX-200 Bone Densitometer, Osteometer Meditech A/S (1997) Summary page 2.

## Indications for use
The DXL CalscanTM Bone Densitometer estimated bone mineral density (BMD) (g/cm 2) for the region of the heel (os calcis). By comparing estimated BMD to a young Caucasian female database, a T-score is calculated so that the physician, at his or her discretion, may assess fracture risk. One patient scan with DXL Calscan takes 55 seconds to perform. The effective patient dose is 0.02 mrem. This performance is substantially equivalent to PIXI performance and poses no new safety or efficacy concerns. Use of the DXL Calscan is restricted to prescription use only. The Operator's Manual for the DXL Calscan contains the following statement: "United States Federal Law restricts this device to the sale, distribution and use by or on the order of a physician."

Source page: https://510kreport.com/device/K033550
Methodology: https://510kreport.com/methodology