510(k) · Cleared

Cleared

Ctxa Hip; Ctxa; QCT Pro Ctxa Hip

K002113510(k) TraditionalCleared Dec 4, 2001545-day reviewClass II21 CFR 892.1170

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mindways Software, Inc. · KGI Densitometer, Bone

Cleared on Dec 4, 2001 as substantially equivalent to K894854 (Image Enhancements, 1989) and 2 other predicates after a 545-day review. Its family tree reaches back 1 generation to 1988. 11 later devices descend from it.

Decided: Dec 4, 2001
Review: 545 days
Class: Class II
Product code: KGI
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K883280 (1988). 3 ancestors in all. 11 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK883280 Hologic QDR-1000 X-Ray Bone Densitometer/ModifiedHologic, Inc. · 1988
This deviceK002113 Ctxa Hip; Ctxa; QCT Pro Ctxa HipMindways Software, Inc. · 2001
Descendant · cites it directly · 6 of its ownK082402 Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008
Descendant · 2 generations on · 5 of its ownK121716 TBS InsightMedimaps Group SA · 2012
Descendant · 3 generations on · 4 of its ownK152299 TBS iNsightMedimaps Group SA · 2016 · Recalled
Descendant · 4 generations on · 2 of its ownK191112 GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · Recalled
Descendant · cites it directly · 1 of its ownK030330 Ctxa Hip Extended Reference DataMindways Software, Inc. · 2003

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2003high 2 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 11 · See all

K082402Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008 · cites it directly6descendants
K121716TBS InsightMedimaps Group SA · 2012 · 2 generations on5descendants
K152299TBS iNsightMedimaps Group SA · 2016 · 3 generations on4descendants
K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · 4 generations on2descendants
K030330Ctxa Hip Extended Reference DataMindways Software, Inc. · 2003 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K883280	Hologic QDR-1000 X-Ray Bone Densitometer/Modified	Hologic, Inc.	1988	—
0 (this device)	K002113	Ctxa Hip; Ctxa; QCT Pro Ctxa Hip	Mindways Software, Inc.	2001	—
+1	K082402	Osdx Hip BMD System	Imaging Therapeutics, Inc.	2008	—
+2	K121716	TBS Insight	Medimaps Group SA	2012	—
+3	K152299	TBS iNsight	Medimaps Group SA	2016	2
+4	K191112	GEHC DXA Bone Densitometers with enCORE version 18	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	2019	1
+1	K030330	Ctxa Hip Extended Reference Data	Mindways Software, Inc.	2003	—

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
2003	2	0
2008	1	0
2012	1	0
2014	1	0
2016	1	0
2019	1	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K002113, 1988–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K894854	QCT Bone Mineral Density Analysis Software Summary page 1 …er 28, 2001 Device/Trade Name: CTXA Hip Common/Usual Name: Bone Mineral Densitometer Classification Name: Bone Densitometer, 21 CFR 892.1170. Class I1 Predicate Devices: K894854: QCT Bone Mincral Density Analysis Software Intended Use: Estimate bone mineral density within the spine. K883280: Hologic QDR…	Image Enhancements	1989	—
*	K883280	Hologic QDR-1000 X-Ray Bone Densitometer/Modified Summary page 1 …tometer, 21 CFR 892.1170. Class I1 Predicate Devices: K894854: QCT Bone Mincral Density Analysis Software Intended Use: Estimate bone mineral density within the spine. K883280: Hologic QDR 1000 X-Ray Bone Densitometer Intended Use: Estimate bone mineral density and bone mineral content at various anatomi…	Hologic, Inc.	1988	—
*	K943505	Hologic QDR-3000 X-Ray Bone Densitometer Summary page 1 …Hologic QDR 1000 X-Ray Bone Densitometer Intended Use: Estimate bone mineral density and bone mineral content at various anatomical sites, including the proximal femur. K943505: Hologic QDR 3000 X-Ray Bone Densitometer Intended Use: Estimate bone mineral density and bone mineral content at various anatomi…	Hologic, Inc.	1995	—
*	—	Norland Model 178 Bone Densitometer Named without a submission number			—

Also cleared against K894854: 3 other devices →

What descends from it? (11)

See all 11

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K082402	Osdx Hip BMD System	Imaging Therapeutics, Inc.	2008	6
K030330	Ctxa Hip Extended Reference Data	Mindways Software, Inc.	2003	1
K254072	BoneVue	Curvebeam AI / Curvebeam, LLC	2026	0
K140342	QCT Pro Asynchronous Calibration Module, Cliniqct	Mindways Software, Inc.	2014	0
K031991	Dxaview Spine and Hip, Model QCT-3D Plus	Image Analysis, Inc.	2003	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?

None of the 3 ancestors has a recall.
Of its descendants, K082402 (Imaging Therapeutics, Inc., 2008) has gone furthest, with 6 descendants of its own.
3 other devices also cite its predicate K894854.

How does its category compare?

All KGI devices

KGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGI

3in 2025

2007high 5 (2008) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KGI

156in 2025

2007high 173 (2008) · low 142 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KGI

1in 2016

2007high 9 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KGI

8in 2025

2007high 16 (2017) · low 0 (2007)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 CTXA Hip Bone Mineral Densitometer is intended to estimate bone mineral content (BMC) and bone mineral density (BMD) in the proximal femur. The BMD estimates can be compared with CTXA Hip-derived reference data. T-scores are calculated with respect to CTXA Hip young normal female reference data, and the T-scores can be used by the physician as an aid in determining fracture risk.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K002113 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002113: Ctxa Hip; Ctxa; QCT Pro Ctxa Hip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002113

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026