# K041266: Pediatric Reference Database

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Aug 11, 2004 after 91 days
- Product code: KGI (Densitometer, Bone)
- Device class: 2
- Regulation: 21 CFR 892.1170
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K973104 (1998). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001812: Pediatric Reference Data, Lunar Corp. (2000) Summary page 1.
- K964307: Expanded Reference Values for DPX Bon Densitometers, Lunar Corp. (1997) Summary page 1.
- K963363: Hologic QDR Series X-Ray Boe Densitometers, Hologic, Inc. (1996) Summary page 1.
- K023398: Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery, Hologic, Inc. (2002) Summary page 1.
- K033224: Hologic QDR Explorer X-Ray Bone Densitometer, Model Explorer, Hologic, Inc. (2003) Summary page 1.
- K943505: Hologic QDR-3000 X-Ray Bone Densitometer, Hologic, Inc. (1995) Summary page 1.

## Recalls of this device
- Sep 15, 2004 · Not classified · Z-0192-05: rotating knob of the rotary style APL valve can become separated from the assembly.

## Indications for use
The Pediatric Reference Database is a software option used with Hologic QDR Series X-Ray Bone Densitometers. The Pediatric Reference Database is for use in determining Z-scores for subjects aged 3-20 years at the discretion of the physician.

Source page: https://510kreport.com/device/K041266
Methodology: https://510kreport.com/methodology