510(k) · Cleared
ClearedBrainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · LLZ System, Image Processing, Radiological
Cleared on Dec 16, 2021 as substantially equivalent to K183105 (Materialise NV, 2019) and 2 other predicates after a 134-day review. Its family tree reaches back 11 generations to 1991. 3 later devices descend from it.
- Decided
- Dec 16, 2021
- Review
- 134 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K913770 (1991). 124 ancestors in all, the oldest K871859 (1987). 3 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations between
- 3 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 1 generation backK170816 Elements Image Fusion, Elements Cranial Distortion Correction…Brainlab AG · 2017
- This deviceK212420 Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements…Brainlab AG · 2021
- Descendant · cites it directly · 1 of its ownK223106 Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion…Brainlab AG · 2023
- Descendant · cites it directly · 0 of its ownK260576 MeVis AVM ContourMeVis Medical Solutions AG · 2026
- Descendant · 2 generations on · 0 of its ownK243633 Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0)…Brainlab AG · 2025
Show all 11 generations
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 9 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 8 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 7 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 6 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 5 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 4 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 3 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 1 generation backK170816 Elements Image Fusion, Elements Cranial Distortion Correction…Brainlab AG · 2017
- This deviceK212420 Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements…Brainlab AG · 2021
Most influential descendants
Showing 3 of 3 · See all- K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG · 2023 · cites it directly1descendant
- K260576MeVis AVM ContourMeVis Medical Solutions AG · 2026 · cites it directly0descendants
- K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −10 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −9 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −8 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −7 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −6 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −5 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −4 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −3 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −2 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| −1 | K170816 | Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine… | Brainlab AG | 2017 | — |
| 0 (this device) | K212420 | Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements… | Brainlab AG | 2021 | — |
| +1 | K223106 | Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion… | Brainlab AG | 2023 | — |
| +1 | K260576 | MeVis AVM Contour | MeVis Medical Solutions AG | 2026 | — |
| +2 | K243633 | Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab… | Brainlab AG | 2025 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (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 | Decided |
|---|---|---|---|
| * | K183105 | Mimics MedicalSummary page 4…ation Number 892.2050 Regulatory Class Class II Panel Radiology Predicate Device(s) Mimics Medical (K183105) – Primary Predicate iPlan (K113732) – Second predicate Image F… | 2019 |
| * | K113732 | Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View, Iplan Spine)Summary page 4…Class II Panel Radiology Predicate Device(s) Mimics Medical (K183105) – Primary Predicate iPlan (K113732) – Second predicate Image Fusion (K170816) – Third predicate Reference Device Br… | 2012 |
| * | K170816 | Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Summary page 4…Mimics Medical (K183105) – Primary Predicate iPlan (K113732) – Second predicate Image Fusion (K170816) – Third predicate Reference Device Brainlab Elements Image Fusion Angio (K190042)… | 2017 |
| † | K190042 | Brainlab Elements Image Fusion Angio | 2019 |
What descends from it? (3)
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)
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 30 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 24 of the 124 ancestors have a recall of any class.
- Of its descendants, K223106 (Brainlab AG, 2023) has gone furthest, with 1 descendant of its own.
- 16 other devices also cite its predicate K183105.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Brainlab Elements Contouring provides an interface with tools and views to outline, refine, combine and manipulate structures in patient image data. The generated 3D structures are not intended to create physical replicas used for diagnostic purposes. The device itself does not have clinical indications. Brainlab Elements Fibertracking is an application for the processing and visualization of cranial white matter tracts based on Diffusion Tensor Imaging…
Read the full statement (152 words)
Brainlab Elements Contouring provides an interface with tools and views to outline, refine, combine and manipulate structures in patient image data. The generated 3D structures are not intended to create physical replicas used for diagnostic purposes. The device itself does not have clinical indications.
Brainlab Elements Fibertracking is an application for the processing and visualization of cranial white matter tracts based on Diffusion Tensor Imaging (DTI) data for use in treatment planning procedures. The device itself does not have clinical indications.
Brainlab Elements Image Fusion is an application for the co-registration of image data within medical procedures by using rigid and deformable registration methods. It is intended to align anatomical structures between data sets. The device itself does not have clinical indications.
Brainlab Elements Image Fusion Angio is a software application that is intended to be used for the co-registration of cerebrovascular image data. The device itself does not have clinical indications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212420 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212420: Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212420
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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