510(k) · Cleared
Recalled · 2009Apex 2.0 Software for QDR X-Ray Bone Densitometers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · KGI Densitometer, Bone
Cleared on Mar 28, 2008 as substantially equivalent to K023398 (Hologic, Inc., 2002) after a 176-day review. Its family tree reaches back 3 generations to 1998. It has been recalled 9 times.
- Decided
- Mar 28, 2008
- Review
- 176 days
- Class
- Class II
- Product code
- KGI
- Recalls
- 9
- Predicates
- 1
Its longest line of descent runs back 3 generations to K973104 (1998). 12 ancestors in all, the oldest K883280 (1988). No later device cites it as a predicate yet.
- Root · 3 generations backK973104 Norland Model Pdexa Bone DensitometerNorland Corp. · 1998
- 2 generations backK983028 Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500…Hologic, Inc. · 1998
- 1 generation backK023398 Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500…Hologic, Inc. · 2002 · Recalled
- This deviceK072847 Apex 2.0 Software for QDR X-Ray Bone DensitometersHologic, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K973104 | Norland Model Pdexa Bone Densitometer | Norland Corp. | 1998 | — |
| −2 | K983028 | Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000… | Hologic, Inc. | 1998 | — |
| −1 | K023398 | Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery | Hologic, Inc. | 2002 | 1 |
| 0 (this device) | K072847 | Apex 2.0 Software for QDR X-Ray Bone Densitometers | Hologic, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KGI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KGI device
- #1 K252718 Lunar Astrascore 13.3 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023398 | Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, DiscoverySummary page 2…Bone Densitometer: 21 CFR 892.1170 G.3.3 Classification Panel Radiology G.3.4 Product Code 90 KGI G.3.5 Predicate Device(s) * 510(k)No.: K023398 Trade Name: Discovery Package for Hologic QDR X-Ray Bone Densitometers SE Date: November 8,… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 7, 2009 | Not classified | Z-1725-2009 | Component design/selection | 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 | Component design/selection | 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 | Component design/selection | 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 | Component design/selection | 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 design | Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. |
| Jun 27, 2008 | Not classified | Z-2184-2008 | Software design | Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. |
| Jun 27, 2008 | Not classified | Z-2185-2008 | Software design | Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. |
| Jun 27, 2008 | Not classified | Z-2188-1991 | Software design | Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. |
| Jun 27, 2008 | Not classified | Z-2186-2008 | Software design | Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 4 other devices also cite its predicate K023398.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KGI
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGI
156in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGI
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGI
8in 2025
MAUDE reports naming product code KGI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 5 | 173 | 6 | 2 |
| 2009 | 1 | — | 9 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 1 | 5 |
| 2012 | 5 | 142 | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 1 | — | 0 | 6 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 3 | 156 | 0 | 8 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072847 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072847: Apex 2.0 Software for QDR X-Ray Bone Densitometers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072847
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026