510(k) · Cleared
ClearedInfant Whole Body Software Option for QDR 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 Oct 29, 2004 as substantially equivalent to K023398 (Hologic, Inc., 2002) and 1 other predicate after a 46-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it.
- Decided
- Oct 29, 2004
- Review
- 46 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K973104 (1998). 13 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 deviceK042480 Infant Whole Body Software Option for QDR DensitometersHologic, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK133664 Encore Version 16 Software for GE Lunar Dxa Bone DensitometersGe Medical Systems Ultrasound & Primary Care Diagn · 2014 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K133664Encore Version 16 Software for GE Lunar Dxa Bone DensitometersGe Medical Systems Ultrasound & Primary Care Diagn · 2014 · 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) | K042480 | Infant Whole Body Software Option for QDR Densitometers | Hologic, Inc. | 2004 | — |
| +1 | K133664 | Encore Version 16 Software for GE Lunar Dxa Bone Densitometers | Ge Medical Systems Ultrasound & Primary Care Diagn | 2014 | 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 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K023398 | Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, DiscoverySummary page 1…Infant Whole Body Software Option for QDR Densitometers Common Name: Software Option for Bone Densitometer F.5 Predicate Device Information K023398 Discovery Package for QDR X-Ray Bone Densitometers K961787 Body Composition Analysis Software for ODR X-Ray Bone Densit… | 2002 |
| * | K961787 | Body Composition Software Option for QDR X-Ray Bone DensitometersSummary page 1…mmon Name: Software Option for Bone Densitometer F.5 Predicate Device Information K023398 Discovery Package for QDR X-Ray Bone Densitometers K961787 Body Composition Analysis Software for ODR X-Ray Bone Densitometers F.6 Device Description and Intended Use The Inf… | 1997 |
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 |
|---|---|---|---|
| K133664 | Encore Version 16 Software for GE Lunar Dxa Bone Densitometers | 2014 | 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 6 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K133664 (Ge Medical Systems Ultrasound & Primary Care Diagn, 2014) has gone furthest, with 0 descendants of its own.
- 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.
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 Infant Whole Body software option for QDR X-Ray Bone Densitometers is an optional data acquisition and analysis method that provides estimates of bone mineral content (BMC, in grams), bone mineral density (BMD, in grams/cm 2), and body composition (lean body mass and fat mass of non-osseous tissues) in human infants from birth to one year of age. These data may be used at the discretion of a physician where medically necessary.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042480 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042480: Infant Whole Body Software Option for QDR Densitometers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042480
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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