# K965226: Expert-XL Total Body Acquisition and Analysis Software

- Pathway: 510(k) (Traditional)
- Applicant: Lunar Corp.
- Decided: Oct 3, 1997 after 277 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- 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 K884625 (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)
- K884625: DPX Bone Densitometer for Total Body Bone Density, Lunar (1989) Summary page 1.
- K935454: DPX Tissue Quantification Output, Lunar Corp. (1995) Summary page 1.

## Indications for use
EXPERT-XL® Total Body Acquisition and Analysis Software is used with the EXPERT-XL® bone densitometer system. This software acquires and estimates BMD, Lean Tissue Mass, and Fat Tissue Mass for the Total Body and sub-regions. The use of the EXPERT-XL® Total Body Acquisition and Analysis Software is restricted to prescription use only. The operator’s manual for the EXPERT-XL system 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.” The EXPERT-XL Total Body Acquisition and Analysis software requires a 3 minute exposure, with an exposure dose of 3 mrem. This software option is substantially equivalent to the DPX Total Body software and poses no new safety or efficacy concerns.

Source page: https://510kreport.com/device/K965226
Methodology: https://510kreport.com/methodology