510(k) · Cleared
ClearedMeVis AVM Contour
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MeVis Medical Solutions AG · LLZ System, Image Processing, Radiological
Cleared on Jun 30, 2026 as substantially equivalent to K212420 (Brainlab AG, 2021) after a 130-day review. Its family tree reaches back 12 generations to 1991.
- Decided
- Jun 30, 2026
- Review
- 130 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K913770 (1991). 125 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations between
- 3 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 2 generations backK170816 Elements Image Fusion, Elements Cranial Distortion Correction…Brainlab AG · 2017
- 1 generation backK212420 Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements…Brainlab AG · 2021
- This deviceK260576 MeVis AVM ContourMeVis Medical Solutions AG · 2026
Show all 12 generations
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 11 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 10 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 9 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 8 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 7 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 6 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 5 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 4 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 3 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 2 generations backK170816 Elements Image Fusion, Elements Cranial Distortion Correction…Brainlab AG · 2017
- 1 generation backK212420 Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements…Brainlab AG · 2021
- This deviceK260576 MeVis AVM ContourMeVis Medical Solutions AG · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −11 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −10 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −9 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −8 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −7 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −6 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −5 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −4 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −3 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| −2 | K170816 | Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine… | Brainlab AG | 2017 | — |
| −1 | K212420 | Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements… | Brainlab AG | 2021 | — |
| 0 (this device) | K260576 | MeVis AVM Contour | MeVis Medical Solutions AG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 9 | 0 |
| 2001 | 16 | 0 |
| 2002 | 12 | 0 |
| 2003 | 7 | 0 |
| 2004 | 12 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2019 | 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? (1)
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 |
|---|---|---|---|
| * | K212420 | Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Summary page 6…Page 1 3 Predicate Device 510(k) Number Predicate Device Product Code K212420 Brainlab Elements, Brainlab Elements Contouring, LLZ, JAK Brainlab Elements Fibertracking, B… | 2021 |
| † | K190042 | Brainlab Elements Image Fusion Angio | 2019 |
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 35 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 24 of the 125 ancestors have a recall of any class.
- 1 other device also cites its predicate K212420.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
MeVis AVM Contour is intended for use by qualified medical professionals working in the field of neurosurgery or radiotherapy planning to manually create target contours for regions of interest in the cranial region through semi-automatic registration of 2D digital subtraction angiography (DSA) images onto 3D computed tomography (CT) scans. The contours can be exported as DICOM RTStruct objects and are used in radiosurgery/-therapy treatment planning…
Read the full statement (176 words)
MeVis AVM Contour is intended for use by qualified medical professionals working in the field of neurosurgery or radiotherapy planning to manually create target contours for regions of interest in the cranial region through semi-automatic registration of 2D digital subtraction angiography (DSA) images onto 3D computed tomography (CT) scans.
The contours can be exported as DICOM RTStruct objects and are used in radiosurgery/-therapy treatment planning procedures to target specific brain regions.
The created contours are intended for further review, editing and approval by radiosurgery/-therapy planning specialists in third-party radiosurgery/-therapy treatment planning systems (not part of this submission).
The semi-automatic registration is restricted to/requires:
• X-ray, 2D DSA and 3D CT images of the brain
• X-ray images must be acquired in both frontal and sagittal direction
Intended Patient Population
MeVis AVM Contour is used for patients diagnosed with Arteriovenous Malformations (AVM) requiring stereotactic radiosurgery (SRS). These patients are adults, 18 years and older.
Intended User Profile
The intended users are qualified medical professionals, working in the field of neurosurgery or radiotherapy planning (Neurosurgeons and Radiation Oncologists).
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/K260576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260576: MeVis AVM Contour.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260576
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026