510(k) · Cleared

Cleared

LMS-Lung/Track

K070868510(k) TraditionalCleared May 15, 200747-day reviewClass II21 CFR 892.2050

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

Median Technologies · LLZ System, Image Processing, Radiological

Cleared on May 15, 2007 as substantially equivalent to K040028 (R2 Technology, Inc., 2004) and 2 other predicates after a 47-day review. Its family tree reaches back 5 generations to 1993.

Decided: May 15, 2007
Review: 47 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 3

Its longest line of descent runs back 5 generations to K930090 (1993). 32 ancestors in all, the oldest K864854 (1987). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK930090 HelicatElscint, Inc. · 1993
4 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
3 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
2 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
1 generation backK023785 Lung Nodule Assessment and Comparison OptionPhilips Medical Systems (Cleveland), Inc. · 2003
This deviceK070868 LMS-Lung/TrackMedian Technologies · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K930090	Helicat	Elscint, Inc.	1993	—
−4	K961464	Select/SP	Elscint, Inc.	1996	3
−3	K982060	Volumax CT Imaging System	Elscint, Inc.	1998	—
−2	K012009	MX8000 Idt CT System	Marconi Medical Systems, Inc.	2001	61
−1	K023785	Lung Nodule Assessment and Comparison Option	Philips Medical Systems (Cleveland), Inc.	2003	—
0 (this device)	K070868	LMS-Lung/Track	Median Technologies	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1989	1	0
1991	1	0
1994	3	0
1995	3	0
1996	3	0
1997	5	0
1998	1	0
1999	1	0
2001	3	0
2002	3	0
2003	1	0
2004	1	0

FIG. 1 — Lineage of K070868, 1993–2007Source: 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 LLZ? 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 LLZ device

#1 K230955 syngo Application Softwarescore 21.5 · 11 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
*	K040028	CA-1500 Summary page 1 …Primelung assessment and comparison option 510(k) K040028 K023785 K024149 Number Device Description FMS-Lung/TRACK provides visualization and analysis tools for ch…	R2 Technology, Inc.	2004	—
*	K023785	Lung Nodule Assessment and Comparison Option Summary page 1 …assessment and comparison option 510(k) K040028 K023785 K024149 Number Device Description FMS-Lung/TRACK provides visualization and analysis tools for chest CT iniages acqu…	Philips Medical Systems (Cleveland), Inc.	2003	—
*	K024149	Primelung Summary page 1 …assessment and comparison option 510(k) K040028 K023785 K024149 Number Device Description FMS-Lung/TRACK provides visualization and analysis tools for chest CT iniages acquired in low or norma…	Accuimage Diagnostics Corp.	2003	—

Also cleared against K040028: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
4 of the 32 ancestors have a recall of any class.
2 other devices also cite its predicate K040028.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

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

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to:

- visualize chest CT datasets acquired in low or normal dose;

- mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user;

- compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation)

- generate automatic reports.

LMS-Lung/Track device is designed to be used in diagnostic thoracic CT examinations in adult patients.

LMS-Lung/Track is not intended to be used for patients with prior thoracotomy.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070868 · printed Nov 4, 2026

Cite this page

510(k) Report. “K070868: LMS-Lung/Track.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070868

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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