# K023398: Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery

- Pathway: 510(k) (Special)
- Applicant: Hologic, Inc.
- Decided: Nov 8, 2002 after 30 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: 2 generations back to K973104 (1998). 11 ancestors in all.
19 later devices descend from it; 5 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992677: Eagle Option for the QDR Bone Densitometer, Models QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W, Hologic, Inc. (1999) Summary page 1.
- K992775: Option for the QDR Bone Densitometer, Models QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W, Hologic, Inc. (1999) Summary page 1.
- K983028: Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W, Hologic, Inc. (1998) Summary page 1.
- K963363: Hologic QDR Series X-Ray Boe Densitometers, Hologic, Inc. (1996) Summary page 1.
- K941362: Bone Mineral Densitometer, Hologic, Inc. (1995) Summary page 1.
- K943505: Hologic QDR-3000 X-Ray Bone Densitometer, Hologic, Inc. (1995) Summary page 1.
- K913321: Hologic QDR-2000 X-Ray Bone Densitometer, Hologic, Inc. (1991) Summary page 1.
- K894795: Hologic QDR-1000/W X-Ray Bone Densitometer, Hologic, Inc. (1990) Summary page 1.
- K883280: Hologic QDR-1000 X-Ray Bone Densitometer/Modified, Hologic, Inc. (1988) Summary page 1.
- K001812: Pediatric Reference Data, Lunar Corp. (2000)

## Most influential descendants
- K061561: Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone Densitometers (2006), 13 descendants of its own
- K072664: GE Lunar Femur Strength Software (2008), 7 descendants of its own
- K082402: Osdx Hip BMD System (2008), 6 descendants of its own
- K121716: TBS Insight (2012), 5 descendants of its own
- K161682: GE Lunar DXA Bone Densitometers with enCORE version 17 (2016), 4 descendants of its own

## Recalls of this device
- Jun 13, 2024 · Class II · Z-2373-2024: Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical eq

## Indications for use
The Discovery Package for QDR X-Ray Bone Densitometers is indicated for the estimation of bone mineral density (BMD), comparison of measured variables obtained from a given QDR scan to a database of reference values, the estimation of fiacture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics using the Hologic QDR@ X-Ray Bone Densitometers.

Source page: https://510kreport.com/device/K023398
Methodology: https://510kreport.com/methodology