510(k) · Cleared
ClearedCtxa Hip Extended Reference Data
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mindways Software, Inc. · KGI Densitometer, Bone
Cleared on Jun 20, 2003 as substantially equivalent to K002113 (Mindways Software, Inc., 2001) after a 140-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.
- Decided
- Jun 20, 2003
- Review
- 140 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K883280 (1988). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK883280 Hologic QDR-1000 X-Ray Bone Densitometer/ModifiedHologic, Inc. · 1988
- 1 generation backK002113 Ctxa Hip; Ctxa; QCT Pro Ctxa HipMindways Software, Inc. · 2001
- This deviceK030330 Ctxa Hip Extended Reference DataMindways Software, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK140342 QCT Pro Asynchronous Calibration Module, CliniqctMindways Software, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K140342QCT Pro Asynchronous Calibration Module, CliniqctMindways Software, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883280 | Hologic QDR-1000 X-Ray Bone Densitometer/Modified | Hologic, Inc. | 1988 | — |
| −1 | K002113 | Ctxa Hip; Ctxa; QCT Pro Ctxa Hip | Mindways Software, Inc. | 2001 | — |
| 0 (this device) | K030330 | Ctxa Hip Extended Reference Data | Mindways Software, Inc. | 2003 | — |
| +1 | K140342 | QCT Pro Asynchronous Calibration Module, Cliniqct | Mindways Software, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 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? (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 |
|---|---|---|---|
| * | K002113 | Ctxa Hip; Ctxa; QCT Pro Ctxa Hip | 2001 |
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 |
|---|---|---|---|
| K140342 | QCT Pro Asynchronous Calibration Module, Cliniqct | 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 15 years and passes through 2 companies; a new generation was cleared every 13.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K140342 (Mindways Software, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K002113.
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 intended use of the CTXA Hip Extended Reference Data accessory for the CTXA Hip Bone Mineral Densitometry module is to provide a context for the clinical interpretation of a patient's proximal femur BMD estimates. T-scores are calculated relative to a US normal female Caucasian reference population age 20-39 years, and 2-scores are calculated relative to a US normal female Caucasian reference population age 20-79 years. The use of a reference data set and the interpretation of parameters derived by the CTXA Hip module when comparing patient-specific BMD estimates to the installed and selected reference data set is at the discretion of the physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030330: Ctxa Hip Extended Reference Data.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030330
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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