# K972053: Pixi Young Adult Referenc Population for OS Calcis and Forearm

- Pathway: 510(k) (Traditional)
- Applicant: Lunar Corp.
- Decided: Aug 8, 1997 after 67 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: 1 generation 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)
- K891582: Modified Osteoanalyzer (# SPSHA110/220), Osteon, Inc. (1989) Summary page 1.
- K931996: Model Pdexa Bone Densitometer, Norland Corp. (1995) Summary page 1.

## Indications for use
The PIXI™ young adult reference population for os calcis and forearm provides the ability to compare the BMD result of the PIXI™ to the value of an average young adult, age 20-45 years old, of the same sex. The results from this comparison are expressed as a percentage of young adults, or as a T-score, defined as a number of standard deviations from the young adult value. This additional feature is highly comparable to similar features in the Norland pDEXA as well as the Osteon Osteoanalyzer densitometers. The use of the PIXI™ young adult reference population for os calcis and forearm, is restricted to prescription use only. The operator’s manual for the PIXI 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.”

Source page: https://510kreport.com/device/K972053
Methodology: https://510kreport.com/methodology