510(k) Report

510(k) · Cleared

Cleared

Expert Spine Morphotietry Reference

K961007510(k) TraditionalCleared Jul 25, 1996135-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

Lunar Corp. · KGI Densitometer, Bone

Cleared on Jul 25, 1996 as substantially equivalent to K950611 (Lunar Corp., 1995) and 1 other predicate after a 135-day review. Its family tree reaches back 1 generation to 1990. 17 later devices descend from it.

Decided
Jul 25, 1996
Review
135 days
Class
Class II
Product code
KGI
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K890121 (1990). 2 ancestors in all. 17 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor2001: 1 descendant cleared2007: 1 descendant cleared2005: 1 descendant cleared2008: 2 descendants cleared2016: 2 descendants cleared2006: 1 descendant cleared2026: 1 descendant cleared2022: 1 descendant cleared2012: 2 descendants cleared2019: 1 descendant cleared2018: 1 descendant cleared2023: 1 descendant cleared2025: 2 descendants clearedK890121 · Modified DPX Bone Densitometer · Lunar · 19901990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 6 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant K890121 · Modified DPX Bone Densitometer · Lunar · 19900+5
  1. Root · 1 generation backK890121 Modified DPX Bone DensitometerLunar · 1990
  2. This deviceK961007 Expert Spine Morphotietry ReferenceLunar Corp. · 1996
  3. Descendant · cites it directly · 16 of its ownK011917 Advanced Hip Assessment SoftwareGe Lunar Corp. · 2001
  4. Descendant · 2 generations on · 13 of its ownK061561 Hip Structural Analysis Software Option for the Hologic QDR X-Ray…Hologic, Inc. · 2006
  5. Descendant · 2 generations on · 7 of its ownK072664 GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008
  6. Descendant · 3 generations on · 6 of its ownK082402 Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008
  7. Descendant · 4 generations on · 5 of its ownK121716 TBS InsightMedimaps Group SA · 2012

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2001: 12005: 12006: 12007: 12008: 22012: 22016: 22018: 12019: 12022: 12023: 12025: 22026: 1
2001high 2 (2008) · low 0 (2002)2026

Most influential descendants

Showing 5 of 17 · See all
  • K011917Advanced Hip Assessment SoftwareGe Lunar Corp. · 2001 · cites it directly16descendants
  • K061561Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone DensitometersHologic, Inc. · 2006 · 2 generations on13descendants
  • K072664GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008 · 2 generations on7descendants
  • K082402Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008 · 3 generations on6descendants
  • K121716TBS InsightMedimaps Group SA · 2012 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K890121Modified DPX Bone DensitometerLunar1990—
0 (this device)K961007Expert Spine Morphotietry ReferenceLunar Corp.1996—
+1K011917Advanced Hip Assessment SoftwareGe Lunar Corp.2001—
+2K061561Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone…Hologic, Inc.2006—
+2K072664GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia2008—
+3K082402Osdx Hip BMD SystemImaging Therapeutics, Inc.2008—
+4K121716TBS InsightMedimaps Group SA2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200510
200610
200710
200820
201220
201620
201810
201910
202210
202310
202520
202610
FIG. 1 — Lineage of K961007, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252718 Lunar Astrascore 13.3 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K950611Expert Morphomerty Softward
Summary page 1
…Trade Name: EXPERT Spine Morphometry Reference Values Classification Name: 21 CFR 892.1170, Bone Densitometer - ® Predicate Device: = EXPERT Spine Morphometry, 510(k) K950611 DPX Bone Densitometer, Reference Values 510(k) K890121 8.1 DESCRIPTION OF THE DEVICE: Reference values of spine morphometry ha…
Lunar Corp.1995—
*K890121Modified DPX Bone Densitometer
Summary page 1
…Classification Name: 21 CFR 892.1170, Bone Densitometer - ® Predicate Device: = EXPERT Spine Morphometry, 510(k) K950611 DPX Bone Densitometer, Reference Values 510(k) K890121 8.1 DESCRIPTION OF THE DEVICE: Reference values of spine morphometry have been-added to the EXPERT Spine Morphometry Software.…
Lunar1990—

Also cleared against K950611: 2 other devices →

What descends from it? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K011917Advanced Hip Assessment SoftwareGe Lunar Corp.200116

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 2 ancestors has a recall.
  • Of its descendants, K011917 (Ge Lunar Corp., 2001) has gone furthest, with 16 descendants of its own.
  • 2 other devices also cite its predicate K950611.

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

2007: 22008: 52009: 12011: 22012: 52013: 12014: 22016: 22018: 12019: 12022: 22023: 12025: 32026 (partial year): 2
2007high 5 (2008) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KGI

156in 2025

2008: 173 days median2012: 142 days median2025: 156 days median
2007high 173 (2008) · low 142 (2012)2026

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

Recalls per year · KGI

1in 2016

2008: 62009: 92011: 12016: 1
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

2008: 22009: 32011: 52012: 12013: 12014: 22016: 12017: 162018: 62020: 22021: 12022: 12023: 22024: 22025: 8
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
2008517362
20091—93
20100—00
20112—15
2012514201
20131—01
20142—02
20150—00
20162—11
20170—016
20181—06
20191—00
20200—02
20210—01
20222—01
20231—02
20240—02
2025315608
20262—0—

Also cleared against K950611

2 other devices cite the same predicate.

  • K023554Dual-Energy Vertebral Assessment View SoftwareGe Lunar Corp. · 2002
  • K011917Advanced Hip Assessment SoftwareGe Lunar Corp. · 2001

More from Lunar Corp.

23 FDA decisions under this applicant name. See the company

  • K001812Pediatric Reference DataLunar Corp. · 2000
  • K001756Lunar Report Generator IILunar Corp. · 2000
  • K000826Prodigy Lateral View SoftwareLunar Corp. · 2000
  • K983564Prodigy Total Body SoftwareLunar Corp. · 1998
  • K983724Orca-DX Bone DensitometerLunar Corp. · 1998

Recent decisions in KGI

The KGI category page

  • K254072BoneVueCurvebeam AI / Curvebeam, LLC · 2026
  • K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026
  • K2510223D-Shaper3D-Shaper Medical S.L · 2025
  • K242295BunkerHill BMDBunkerHill Health · 2025
  • K243218TBS iNsight (V4)Medimaps Group SA · 2025

https://510kreport.com/device/K961007 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961007: Expert Spine Morphotietry Reference.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961007

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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