510(k) · Cleared

Cleared

Dual-Energy Vertebral Assessment View Software

K023554510(k) TraditionalCleared Dec 20, 200258-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 Dec 20, 2002 as substantially equivalent to K000826 (Lunar Corp., 2000) and 2 other predicates after a 58-day review. Its family tree reaches back 1 generation to 1995. 6 later devices descend from it.

Decided: Dec 20, 2002
Review: 58 days
Class: Class II
Product code: KGI
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K950611 (1995). 3 ancestors in all. 6 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK950611 Expert Morphomerty SoftwardLunar Corp. · 1995
This deviceK023554 Dual-Energy Vertebral Assessment View SoftwareGe Lunar Corp. · 2002
Descendant · cites it directly · 2 of its ownK103475 Spineanalyer Model SapocOptasia Medical · 2011
Descendant · cites it directly · 1 of its ownK052581 Lunar IdxaGe Medical Systems Ultrasound and Primary Care Dia · 2005 · Recalled
Descendant · 2 generations on · 0 of its ownK252718 Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026
Descendant · cites it directly · 0 of its ownK171435 VirtuOst Vertebral Fracture AssessmentO.N. Diagnostics, LLC · 2018
Descendant · 2 generations on · 0 of its ownK120288 Orthocad Software OptionEsaote, S.p.A. · 2012

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2005high 1 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 6 · See all

K103475Spineanalyer Model SapocOptasia Medical · 2011 · cites it directly2descendants
K052581Lunar IdxaGe Medical Systems Ultrasound and Primary Care Dia · 2005 · cites it directly1descendant
K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026 · 2 generations on0descendants
K171435VirtuOst Vertebral Fracture AssessmentO.N. Diagnostics, LLC · 2018 · cites it directly0descendants
K120288Orthocad Software OptionEsaote, S.p.A. · 2012 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K950611	Expert Morphomerty Softward	Lunar Corp.	1995	—
0 (this device)	K023554	Dual-Energy Vertebral Assessment View Software	Ge Lunar Corp.	2002	—
+1	K103475	Spineanalyer Model Sapoc	Optasia Medical	2011	—
+1	K052581	Lunar Idxa	Ge Medical Systems Ultrasound and Primary Care Dia	2005	1
+2	K252718	Lunar Astra	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	2026	—
+1	K171435	VirtuOst Vertebral Fracture Assessment	O.N. Diagnostics, LLC	2018	—
+2	K120288	Orthocad Software Option	Esaote, S.p.A.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	1	0
2011	1	0
2012	1	0
2018	1	0
2026	1	0

FIG. 1 — Lineage of K023554, 1995–2026Source: 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
*	K000826	Prodigy Lateral View Software	Lunar Corp.	2000	—
*	K950611	Expert Morphomerty Softward Summary page 1 …teral View software 5 10 (k) KO00826 LUNAR EXPERT Morphometry Software 5 1O(k) K9506 11 Hologic Morphometry I1 option 5 1O(k)…	Lunar Corp.	1995	—
*	K992775	Option for the QDR Bone Densitometer, Models QDR4500, QDR2000, QDR1500, QDR4000… Summary page 1 …5 1O(k) K9506 11 Hologic Morphometry I1 option 5 1O(k) K992775 10.1 DESCRIPTION OF THE DEVICE: The Dual-energy Vertebral Assessment View Software enables imaging of the spine for…	Hologic, Inc.	1999	—

Also cleared against K000826: 2 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K103475	Spineanalyer Model Sapoc	Optasia Medical	2011	2
K052581	Lunar Idxa	Ge Medical Systems Ultrasound and Primary Care Dia	2005	1
K171435	VirtuOst Vertebral Fracture Assessment	O.N. Diagnostics, LLC	2018	0
K072439	GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile Kit	Ge Medical Systems Ultrasound and Primary Care Dia	2007	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, K103475 (Optasia Medical, 2011) has gone furthest, with 2 descendants of its own.
2 other devices also cite its predicate K000826.

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?

Dual-energy Vertebral Assessment View Software is used with the Prodigy bone densitometer. This software provides an x-ray image of the spine for qualitative visual assessment in order to identify vertebral deformations and estimate vertebral heights (morphometry).

The use of the Prodigy Bone Densitometer is restricted to prescription use only. The operator’s manual for the Prodigy contains the following statement:

“United States Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician.”

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023554 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023554: Dual-Energy Vertebral Assessment View Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023554

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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