510(k) · Cleared
Recalled · Class II · 2026mint Lesion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mint Medical GmbH · LLZ System, Image Processing, Radiological
Cleared on Apr 13, 2015 as substantially equivalent to K111642 (Translational Sciences Corporation, 2011) and 1 other predicate after a 208-day review. Its family tree reaches back 13 generations to 1991. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 13, 2015
- Review
- 208 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 13 generations to K913770 (1991). 146 ancestors in all, the oldest K871859 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations between
- 3 generations backK113029 Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2011
- 2 generations backK123577 Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2013
- 1 generation backK133644 Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2014
- This deviceK142647 mint LesionMint Medical GmbH · 2015
- Descendant · cites it directly · 0 of its ownK220929 ExcelsiorMerit Cro, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK202229 AI MetricsAi Metrics, LLC · 2020
Show all 13 generations
- Root · 13 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 12 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 11 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 10 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 9 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 8 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 7 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 6 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 5 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 4 generations backK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- 3 generations backK113029 Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2011
- 2 generations backK123577 Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2013
- 1 generation backK133644 Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2014
- This deviceK142647 mint LesionMint Medical GmbH · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −12 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −11 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −10 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −9 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −8 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −7 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −6 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −5 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −4 | K093621 | Syngo.Pet&CT Oncology | Siemens Medical Solutions USA, Inc. | 2010 | — |
| −3 | K113029 | Syngo Via MI Workflows | Siemens Medical Solutions USA, Inc. | 2011 | — |
| −2 | K123577 | Syngo.Via MI Workflows | Siemens Medical Solutions USA, Inc. | 2013 | — |
| −1 | K133644 | Syngo.Via MI Workflows | Siemens Medical Solutions USA, Inc. | 2014 | — |
| 0 (this device) | K142647 | mint Lesion | Mint Medical GmbH | 2015 | — |
| +1 | K220929 | Excelsior | Merit Cro, Inc. | 2022 | — |
| +1 | K202229 | AI Metrics | Ai Metrics, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 7 | 0 |
| 1998 | 11 | 0 |
| 1999 | 5 | 0 |
| 2000 | 9 | 0 |
| 2001 | 14 | 0 |
| 2002 | 11 | 0 |
| 2003 | 5 | 0 |
| 2004 | 12 | 0 |
| 2005 | 10 | 0 |
| 2006 | 7 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K111642 | Onco Trac Model 1, 2, 4Summary page 5…Manufacturer 510(k) Number OncoTrac Mint Medical GmbH K111642 (Nov 18, 2011) (Primary Predicative Device) Germany Siemens Medical Syngo.via Ml Workflows… | 2011 |
| * | K133644 | Syngo.Via MI WorkflowsSummary page 5…2 (Nov 18, 2011) (Primary Predicative Device) Germany Siemens Medical Syngo.via Ml Workflows K133644 (Feb 25, 2014) Solutions USA, Inc Device Description mint Lesion™ is a software based Pictur… | 2014 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 7, 2026 | Class II | Z-2068-2026 | Under Investigation by firm | If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients. |
| Nov 15, 2024 | Class II | Z-0709-2025 | Software design | Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images. |
| Nov 15, 2024 | Class II | Z-0710-2025 | Software design | Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 35 of the 146 ancestors have a recall of any class.
- Of its descendants, K220929 (Merit Cro, Inc., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Mint Lesion is a software solution intended to be used for viewing, manipulation, communication, storage, 3D-visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. Mint Lesion is a software only medical device which will be delivered on CDROM / DVD to be installed by trained service personnel. Mint Lesion is a medical diagnostic application for viewing, manipulation, 3D visualization and comparison of…
Read the full statement (225 words)
Mint Lesion is a software solution intended to be used for viewing, manipulation, communication, storage, 3D-visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. Mint Lesion is a software only medical device which will be delivered on CDROM / DVD to be installed by trained service personnel.
Mint Lesion is a medical diagnostic application for viewing, manipulation, 3D visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MPR, MIP and volume rendering.
Mint Lesion enables visualization of information that would otherwise have to be visually compared disjointedly. Mint Lesion provides analytical tools to help the user assess, and document the stage of a disease and/or the response to therapy in accordance with user selected standards. Mint Lesion supports the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Oncology, and Nuclear Medicine environments.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. Mint Lesion is a complement to these standard procedures. Mint Lesion is not to be used in mammography.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142647: mint Lesion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142647
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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