# K072847: Apex 2.0 Software for QDR X-Ray Bone Densitometers

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Mar 28, 2008 after 176 days
- Product code: KGI (Densitometer, Bone)
- Device class: 2
- Regulation: 21 CFR 892.1170
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K973104 (1998). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023398: Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery, Hologic, Inc. (2002) Summary page 2.

## Recalls of this device
- Apr 7, 2009 · Not classified · Z-1725-2009: System may not turn off at the end of the x-ray and cause additional x-ray exposure
- Apr 7, 2009 · Not classified · Z-1727-2009: System may not turn off at the end of the x-ray and cause additional x-ray exposure
- Apr 7, 2009 · Not classified · Z-1726-2009: System may not turn off at the end of the x-ray and cause additional x-ray exposure
- Apr 7, 2009 · Not classified · Z-1728-2009: System may not turn off at the end of the x-ray and cause additional x-ray exposure
- Jun 27, 2008 · Not classified · Z-2187-2008: Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate.
- Jun 27, 2008 · Not classified · Z-2184-2008: Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate.
- Jun 27, 2008 · Not classified · Z-2185-2008: Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate.
- Jun 27, 2008 · Not classified · Z-2188-1991: Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate.
- Jun 27, 2008 · Not classified · Z-2186-2008: Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate.

## Indications for use
The APEX 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 fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics using the Hologic QDR®X-Ray Bone Densitometers. IVA scans are intended for the visualization or quantitative assessment of vertebral bone deformities. IVA also allows the visualization of abdominal aortic calcification, and, if present, clinical correlation may be advised since abdominal aortic calcification may be associated with cardiovascular disease.

Source page: https://510kreport.com/device/K072847
Methodology: https://510kreport.com/methodology