510(k) · Cleared

Cleared

DPX Tissue Quantification Output

K935454510(k) TraditionalCleared Oct 19, 1995706-day reviewClass II21 CFR 892.1750

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

Lunar Corp. · JAK System, X-Ray, Tomography, Computed

Cleared on Oct 19, 1995 after a 706-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it.

Decided: Oct 19, 1995
Review: 706 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 0

17 later devices descend from it, 3 citing it directly.

This deviceK935454 DPX Tissue Quantification OutputLunar Corp. · 1995
Descendant · cites it directly · 12 of its ownK973459 Norland Body Composition Option for Norland Dexa Bone DensitometersNorland Corp. · 1998
Descendant · 2 generations on · 10 of its ownK071570 GE Lunar Body Composition SoftwareGe Medical Systems Lunar · 2007
Descendant · 3 generations on · 5 of its ownK113286 Encore 14 Software Release for the GE Lunar Dxa Bone DensitometersGe Medical Systems Lunar · 2012
Descendant · 3 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 · cites it directly · 3 of its ownK983564 Prodigy Total Body SoftwareLunar Corp. · 1998

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

1997high 2 (1998) · low 0 (2000)2026

Most influential descendants

Showing 5 of 17 · See all

K973459Norland Body Composition Option for Norland Dexa Bone DensitometersNorland Corp. · 1998 · cites it directly12descendants
K071570GE Lunar Body Composition SoftwareGe Medical Systems Lunar · 2007 · 2 generations on10descendants
K113286Encore 14 Software Release for the GE Lunar Dxa Bone DensitometersGe Medical Systems Lunar · 2012 · 3 generations on5descendants
K161682GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016 · 3 generations on4descendants
K983564Prodigy Total Body SoftwareLunar Corp. · 1998 · cites it directly3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K935454	DPX Tissue Quantification Output	Lunar Corp.	1995	—
+1	K973459	Norland Body Composition Option for Norland Dexa Bone Densitometers	Norland Corp.	1998	—
+2	K071570	GE Lunar Body Composition Software	Ge Medical Systems Lunar	2007	—
+3	K113286	Encore 14 Software Release for the GE Lunar Dxa Bone Densitometers	Ge Medical Systems Lunar	2012	—
+3	K161682	GE Lunar DXA Bone Densitometers with enCORE version 17	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	2016	1
+1	K983564	Prodigy Total Body Software	Lunar Corp.	1998	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	2	0
1999	1	0
2005	1	0
2007	2	0
2009	1	0
2011	2	0
2012	2	0
2016	1	0
2018	1	0
2019	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K935454, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JAK? 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 JAK device

#1 K230223 iCAC Devicescore 23.5 · 12 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K973459	Norland Body Composition Option for Norland Dexa Bone Densitometers	Norland Corp.	1998	12
K983564	Prodigy Total Body Software	Lunar Corp.	1998	3
K965226	Expert-XL Total Body Acquisition and Analysis Software	Lunar Corp.	1997	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?

Of its descendants, K973459 (Norland Corp., 1998) has gone furthest, with 12 descendants of its own.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAK

27in 2025

2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007high 200 (2014) · low 27 (2007)2026

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

Recalls per year · JAK

17in 2025

2007high 51 (2010) · low 5 (2019)2026

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

Adverse event reports per year · JAK

219in 2025

2007high 543 (2018) · low 76 (2007)2025

MAUDE reports naming product code JAK, 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	14	27	11	76
2008	26	42	16	120
2009	15	31	29	105
2010	7	92	51	119
2011	16	155	34	205
2012	28	121	23	192
2013	17	132	11	414
2014	30	200	10	308
2015	30	140	28	454
2016	25	129	44	365
2017	29	96	33	338
2018	24	114	10	543
2019	28	94	5	233
2020	30	112	8	177
2021	20	145	15	261
2022	30	131	9	199
2023	27	139	9	310
2024	26	141	20	212
2025	27	141	17	219
2026	21	167	23	—

https://510kreport.com/device/K935454 · printed Nov 6, 2026

Cite this page

510(k) Report. “K935454: DPX Tissue Quantification Output.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935454

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026