510(k) · Cleared
Recalled · Class II · 2024Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery
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 8, 2002 as substantially equivalent to K992677 (Hologic, Inc., 1999) and 9 other predicates after a 30-day review. Its family tree reaches back 2 generations to 1998. 19 later devices descend from it. It has been recalled once.
- Decided
- Nov 8, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- KGI
- Recalls
- 1
- Predicates
- 10
Its longest line of descent runs back 2 generations to K973104 (1998). 11 ancestors in all, the oldest K883280 (1988). 19 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK973104 Norland Model Pdexa Bone DensitometerNorland Corp. · 1998
- 1 generation backK983028 Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500…Hologic, Inc. · 1998
- This deviceK023398 Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500…Hologic, Inc. · 2002
- Descendant · cites it directly · 13 of its ownK061561 Hip Structural Analysis Software Option for the Hologic QDR X-Ray…Hologic, Inc. · 2006
- Descendant · 2 generations on · 7 of its ownK072664 GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008
- Descendant · 2 generations on · 6 of its ownK082402 Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008
- Descendant · 3 generations on · 5 of its ownK121716 TBS InsightMedimaps Group SA · 2012
- Descendant · 3 generations on · 4 of its ownK161682 GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016 · Recalled
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K061561Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone DensitometersHologic, Inc. · 2006 · cites it directly13descendants
- K072664GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008 · 2 generations on7descendants
- K082402Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008 · 2 generations on6descendants
- K121716TBS InsightMedimaps Group SA · 2012 · 3 generations on5descendants
- K161682GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973104 | Norland Model Pdexa Bone Densitometer | Norland Corp. | 1998 | — |
| −1 | K983028 | Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000… | Hologic, Inc. | 1998 | — |
| 0 (this device) | K023398 | Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery | Hologic, Inc. | 2002 | — |
| +1 | K061561 | Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone… | Hologic, Inc. | 2006 | — |
| +2 | K072664 | GE Lunar Femur Strength Software | Ge Medical Systems Ultrasound and Primary Care Dia | 2008 | — |
| +2 | K082402 | Osdx Hip BMD System | Imaging Therapeutics, Inc. | 2008 | — |
| +3 | K121716 | TBS Insight | Medimaps Group SA | 2012 | — |
| +3 | K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016 | 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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (10)
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 |
|---|---|---|---|
| * | K992677 | Eagle Option for the QDR Bone Densitometer, Models QDR4500, QDR2000, QDR1500, QDR4000…Summary page 1…Trade Name: Discovery Package for Hologic QDR X-Ray Bone Densitometers Device Common Name: X-Ray Bone Densitometer Predicate Devices: K992677 Windows 98 "Eagle" Software for QDR Densitometers K992775 Assessment of Vertebral Deformities Usin… | 1999 |
| * | K992775 | Option for the QDR Bone Densitometer, Models QDR4500, QDR2000, QDR1500, QDR4000…Summary page 1…ce Common Name: X-Ray Bone Densitometer Predicate Devices: K992677 Windows 98 "Eagle" Software for QDR Densitometers K992775 Assessment of Vertebral Deformities Using QDR Densitometers K983028 Fracture Risk Estimation for QDR Densitometers… | 1999 |
| * | K983028 | Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000, QDR1500…Summary page 1…K992677 Windows 98 "Eagle" Software for QDR Densitometers K992775 Assessment of Vertebral Deformities Using QDR Densitometers K983028 Fracture Risk Estimation for QDR Densitometers K963363 Reference Databases (MIANES S o h a r e ) f… | 1998 |
| * | K963363 | Hologic QDR Series X-Ray Boe DensitometersSummary page 1…K992775 Assessment of Vertebral Deformities Using QDR Densitometers K983028 Fracture Risk Estimation for QDR Densitometers K963363 Reference Databases (MIANES S o h a r e ) for QDR Densitometers K941362 Vertebral Morphometry Anal… | 1996 |
| * | K941362 | Bone Mineral DensitometerSummary page 1…sk Estimation for QDR Densitometers K963363 Reference Databases (MIANES S o h a r e ) for QDR Densitometers K941362 Vertebral Morphometry Analysis Software for QDR Densitometers K943505 QDR 4500 X-Ray Bone Densitom… | 1995 |
| * | K943505 | Hologic QDR-3000 X-Ray Bone DensitometerSummary page 1…S S o h a r e ) for QDR Densitometers K941362 Vertebral Morphometry Analysis Software for QDR Densitometers K943505 QDR 4500 X-Ray Bone Densitometer K9 13321 QDR 2000 X-Ray Bone Densitometer… | 1995 |
| * | K913321 | Hologic QDR-2000 X-Ray Bone DensitometerSummary page 1…1362 Vertebral Morphometry Analysis Software for QDR Densitometers K943505 QDR 4500 X-Ray Bone Densitometer K9 13321 QDR 2000 X-Ray Bone Densitometer K894795 QDR l00OW X-Ray Bone Densitometer… | 1991 |
| * | K894795 | Hologic QDR-1000/W X-Ray Bone DensitometerSummary page 1…K943505 QDR 4500 X-Ray Bone Densitometer K9 13321 QDR 2000 X-Ray Bone Densitometer K894795 QDR l00OW X-Ray Bone Densitometer K883280 QDR 1000 X-Ray Bone Densitometer… | 1990 |
| * | K883280 | Hologic QDR-1000 X-Ray Bone Densitometer/ModifiedSummary page 1…K9 13321 QDR 2000 X-Ray Bone Densitometer K894795 QDR l00OW X-Ray Bone Densitometer K883280 QDR 1000 X-Ray Bone Densitometer KO0 1812 Pediatric Reference Data for Lunar Bone Densitometer… | 1988 |
| * | K001812 | Pediatric Reference Data | 2000 |
What descends from it? (19)
See all 195 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061561 | Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone Densitometers | 2006 | 13 |
| K042480 | Infant Whole Body Software Option for QDR Densitometers | 2004 | 1 |
| K033224 | Hologic QDR Explorer X-Ray Bone Densitometer, Model Explorer | 2003 | 1 |
| K072847 | Apex 2.0 Software for QDR X-Ray Bone Densitometers | 2008 | 0 |
| K041266 | Pediatric Reference Database | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 13, 2024 | Class II | Z-2373-2024 | Under Investigation by firm | 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 equipment, where the result from the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K061561 (Hologic, Inc., 2006) has gone furthest, with 13 descendants of its own.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023398: Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023398
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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