510(k) · Cleared

Cleared

Iva (Mxa II Software Option)

K060111510(k) TraditionalCleared Apr 24, 200697-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

Cleared on Apr 24, 2006 as substantially equivalent to K941362 (Hologic, Inc., 1995) and 2 other predicates after a 97-day review. Its family tree reaches back 1 generation to 1994. 6 later devices descend from it.

Decided: Apr 24, 2006
Review: 97 days
Class: Class II
Product code: KGI
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K945668 (1994). 3 ancestors in all. 6 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK945668 KXO-80GToshiba America Medical Systems, In.C · 1994
This deviceK060111 Iva (Mxa II Software Option)Hologic, Inc. · 2006
Descendant · cites it directly · 5 of its ownK130277 Single Energy (SE) Femur ExamsHologic, Inc. · 2013
Descendant · 2 generations on · 4 of its ownK161682 GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016 · Recalled
Descendant · 3 generations on · 2 of its ownK191112 GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · Recalled
Descendant · 4 generations on · 0 of its ownK252718 Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026
Descendant · 4 generations on · 0 of its ownK251022 3D-Shaper3D-Shaper Medical S.L · 2025

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2013high 1 (2013) · low 0 (2014)2026

Most influential descendants

Showing 5 of 6 · See all

K130277Single Energy (SE) Femur ExamsHologic, Inc. · 2013 · cites it directly5descendants
K161682GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016 · 2 generations on4descendants
K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · 3 generations on2descendants
K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026 · 4 generations on0descendants
K2510223D-Shaper3D-Shaper Medical S.L · 2025 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945668	KXO-80G	Toshiba America Medical Systems, In.C	1994	—
0 (this device)	K060111	Iva (Mxa II Software Option)	Hologic, Inc.	2006	—
+1	K130277	Single Energy (SE) Femur Exams	Hologic, Inc.	2013	—
+2	K161682	GE Lunar DXA Bone Densitometers with enCORE version 17	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	2016	1
+3	K191112	GEHC DXA Bone Densitometers with enCORE version 18	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	2019	1
+4	K252718	Lunar Astra	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	2026	—
+4	K251022	3D-Shaper	3D-Shaper Medical S.L	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2016	1	0
2018	1	0
2019	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K060111, 1994–2026Source: 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? (3)

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
*	K941362	Bone Mineral Densitometer Summary page 1 …tometer Device Classification: Bone Densitometer 21 CFR 892.1170 Predicate Devices: Hologic Vertebral Morphometry Software Option (K941362) Hologic Vertebral Morphometry Software II Option (K992775) General use x-r…	Hologic, Inc.	1995	—
*	K992775	Option for the QDR Bone Densitometer, Models QDR4500, QDR2000, QDR1500, QDR4000… Summary page 1 …892.1170 Predicate Devices: Hologic Vertebral Morphometry Software Option (K941362) Hologic Vertebral Morphometry Software II Option (K992775) General use x-ray systems (e.g., Toshiba KXO-80G x-ray generator; K.945668…	Hologic, Inc.	1999	—
*	K945668	KXO-80G Summary page 2 …510(k) K060111 Hologic, Inc. respectively), and that of general diagnostic x-ray systems, such as the Toshiba KXO-806 x-ray generator (K945668). Clinical data presented in the submission support the new claim.…	Toshiba America Medical Systems, In.C	1994	—

Also cleared against K941362: 1 other device →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K130277	Single Energy (SE) Femur Exams	Hologic, Inc.	2013	5

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, K130277 (Hologic, Inc., 2013) has gone furthest, with 5 descendants of its own.
1 other device also cites its predicate K941362.

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?

IVA scans are intended for the visualization or quantitative assessment of vertebral bone deformities. IVA also allows the visualization of abdominal aortic calcification, and, if present, clinical correlation may be advised since abdominal aortic calcification may be associated with cardiovascular disease.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060111 · printed Nov 5, 2026

Cite this page

510(k) Report. “K060111: Iva (Mxa II Software Option).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060111

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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