# K983724: Orca-DX Bone Densitometer

- Pathway: 510(k) (Traditional)
- Applicant: Lunar Corp.
- Decided: Dec 8, 1998 after 47 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 1.

## Indications for use
The ORCA-DX® Bone Densitometer provides an estimate of BMD for the heel and forearm. The ORCA-DX® Bone Densitometer requires a 4-second exposure for BMD with a skin entrance dose of <10 mrem. This instrument is comparable to the Lunar PIXI densitometer. The ORCA-DX® Bone Densitometer poses no new safety or efficacy concems. The use of the ORCA-DX® Bone Densitometer is restricted to prescription use only. The operator’s manual for the system contains the following statement: “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/K983724
Methodology: https://510kreport.com/methodology