510(k) · Cleared
ClearedLMS-Liver
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Median Technologies · LLZ System, Image Processing, Radiological
Cleared on Jun 8, 2007 as substantially equivalent to K061671 (Siemens Medical Solutions, 2006) and 1 other predicate after a 36-day review. Its family tree reaches back 8 generations to 1995. 9 later devices descend from it.
- Decided
- Jun 8, 2007
- Review
- 36 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K945512 (1995). 45 ancestors in all, the oldest K871859 (1987). 9 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 7 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 6 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- 5 generations backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- 4 generations backK022919 Smart Breath Respiratory Compensation OptionGE Medical Systems · 2002
- 3 generations backK032915 Advantage 4D OptionGe Medical Systems, LLC · 2003
- 2 generations backK052345 Advantage Sim MDGE Healthcare · 2005 · Recalled
- 1 generation backK061671 Syngo Trued, Model VC10ASiemens Medical Solutions · 2006
- This deviceK071241 LMS-LiverMedian Technologies · 2007
- Descendant · cites it directly · 8 of its ownK121213 VitreaadvancedVital Images, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 5 of its ownK142521 Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014
- Descendant · 3 generations on · 4 of its ownK151988 Visible Patient SuiteVisible Patient, Sas · 2015
- Descendant · 4 generations on · 3 of its ownK212896 Visible Patient SuiteVisible Patient, Sas · 2021
- Descendant · 5 generations on · 1 of its ownK250237 InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K121213VitreaadvancedVital Images, Inc. · 2012 · cites it directly8descendants
- K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014 · 2 generations on5descendants
- K151988Visible Patient SuiteVisible Patient, Sas · 2015 · 3 generations on4descendants
- K212896Visible Patient SuiteVisible Patient, Sas · 2021 · 4 generations on3descendants
- K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −7 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −6 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| −5 | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Medical Systems | 2002 | — |
| −4 | K022919 | Smart Breath Respiratory Compensation Option | GE Medical Systems | 2002 | — |
| −3 | K032915 | Advantage 4D Option | Ge Medical Systems, LLC | 2003 | — |
| −2 | K052345 | Advantage Sim MD | GE Healthcare | 2005 | 3 |
| −1 | K061671 | Syngo Trued, Model VC10A | Siemens Medical Solutions | 2006 | — |
| 0 (this device) | K071241 | LMS-Liver | Median Technologies | 2007 | — |
| +1 | K121213 | Vitreaadvanced | Vital Images, Inc. | 2012 | 1 |
| +2 | K142521 | Synapse 3D Liver and Kidney Analysis | Fujifilm Meidcal Systems U.S.A.,Inc. | 2014 | — |
| +3 | K151988 | Visible Patient Suite | Visible Patient, Sas | 2015 | — |
| +4 | K212896 | Visible Patient Suite | Visible Patient, Sas | 2021 | — |
| +5 | K250237 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 9 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061671 | Syngo Trued, Model VC10ASummary page 2…software Cedara PET/CT 51 0(k) K061671 K053301 Software only solution444 Windows XP operating system444 CT scans aslInput444 S… | 2006 |
| * | K053301 | Cedara I-Response Cedara Pet/CTSummary page 2…software Cedara PET/CT 51 0(k) K061671 K053301 Software only solution444 Windows XP operating system444 CT scans aslInput444 Support the onc… | 2006 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121213 | Vitreaadvanced | 2012 | 8 |
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 12 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 17 of the 45 ancestors have a recall of any class.
- Of its descendants, K121213 (Vital Images, Inc., 2012) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K061671.
How does its category compare?
All LLZ devicesLLZ 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
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 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-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist radiologists in the evaluation and documentation of lesions. It also provides tools for assessment of lesion evolution over time. LMS-Liver offers measurement tools and 3D registration techniques for characterization and follow-up of the lesions. It also offers reporting capabilities making it possible to generate standardized reports.
LMS-Liver is intended to be used by radiologists and other clinicians qualified to interpret CT images.
LMS-Liver device is designed to be used with CT images covering the liver area in adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071241 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071241: LMS-Liver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071241
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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