510(k) · Cleared
ClearedHologic QDR Explorer X-Ray Bone Densitometer, Model Explorer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · KGI Densitometer, Bone
Cleared on Nov 5, 2003 as substantially equivalent to K943505 (Hologic, Inc., 1995) and 1 other predicate after a 30-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it.
- Decided
- Nov 5, 2003
- Review
- 30 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K973104 (1998). 12 ancestors in all, the oldest K883280 (1988). 1 later device descends from it, 1 citing it directly.
- 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 deviceK033224 Hologic QDR Explorer X-Ray Bone Densitometer, Model ExplorerHologic, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK041266 Pediatric Reference DatabaseHologic, Inc. · 2004 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K041266Pediatric Reference DatabaseHologic, Inc. · 2004 · cites it directly0descendants
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) | K033224 | Hologic QDR Explorer X-Ray Bone Densitometer, Model Explorer | Hologic, Inc. | 2003 | — |
| +1 | K041266 | Pediatric Reference Database | Hologic, Inc. | 2004 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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? (2)
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 |
|---|---|---|---|
| * | K943505 | Hologic QDR-3000 X-Ray Bone DensitometerSummary page 2…70 Product Code: 90 KGI Classification II Classification Panel Radiology E.5 Predicate Device Information K943505 Hologic QDR-3000 X-Ray Bone Densitometer KO23398 Hologic Discovery Package for QDR X-Ray Bone Densitometers E.… | 1995 |
| * | K023398 | Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, DiscoverySummary page 3…Based Operating System (K992677) Windows XP-Based Operating System (K023398) PC Hardware Requirements >1 - .O GHz processor -… | 2002 |
| † | K992677 | Eagle Option for the QDR Bone Densitometer, Models QDR4500, QDR2000, QDR1500, QDR4000… | 1999 |
| † | K983028 | Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000, QDR1500… | 1998 |
| † | K963363 | Hologic QDR Series X-Ray Boe Densitometers | 1996 |
| † | K961787 | Body Composition Software Option for QDR X-Ray Bone Densitometers | 1997 |
| † | K002711 | Hologic QDR X-Ray Bone Densitometer/Models Series 4500, 4000, 2000, 1000 and Hologic… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041266 | Pediatric Reference Database | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K041266 (Hologic, Inc., 2004) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K943505.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Hologic QDR Explorer is a fan beam X-Ray Bone Densitometer indicated for (1) the measurement of bone mineral content (BMC) and the estimation of bone mineral density (BMD), (2) comparison of measurements to reference databases, (3) the estimation of fracture risk, (4) body composition analysis, and (5) measurement of periprosthetic BMD
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033224: Hologic QDR Explorer X-Ray Bone Densitometer, Model Explorer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033224
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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