510(k) · Cleared
ClearedVisia Neuro
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 Feb 16, 2012 as substantially equivalent to K081262 (Invivo Corporation, 2008) after a 62-day review. Its family tree reaches back 4 generations to 1991. 3 of the 17 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Feb 16, 2012
- Review
- 62 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K913475 (1991). 15 ancestors in all. 1 later device descends from it, 1 citing it directly. 3 of the 17 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK913475 Magnetic Resonance Diagnostic DeviceGE Medical Systems · 1991
- 3 generations backK960265 Advantage Windows with Functool OptionGE Medical Systems · 1996 · Recalled
- 2 generations backK971965 Philips EasyvisionPhilips Medical Systems, Inc. · 1998
- 1 generation backK081262 DC NeuroInvivo Corporation · 2008
- This deviceK113701 Visia NeuroMeVis Medical Solutions AG · 2012
- Descendant · cites it directly · 0 of its ownK141514 Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913475 | Magnetic Resonance Diagnostic Device | GE Medical Systems | 1991 | — |
| −3 | K960265 | Advantage Windows with Functool Option | GE Medical Systems | 1996 | 1 |
| −2 | K971965 | Philips Easyvision | Philips Medical Systems, Inc. | 1998 | — |
| −1 | K081262 | DC Neuro | Invivo Corporation | 2008 | — |
| 0 (this device) | K113701 | Visia Neuro | MeVis Medical Solutions AG | 2012 | — |
| +1 | K141514 | Synapse 3D Tensor Analysis | Fujifilm Meidcal Systems U.S.A.,Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 1 |
| 2005 | 2 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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.
3 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K081262 | DC NeuroSummary page 3…I Submission Reference VisiaTM Neuro DC Neuro K081 262 Safety and Effectiveness The Visia TM Neuro labeling contains instructions for use and necessary cautions, warnings and notes… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141514 | Synapse 3D Tensor Analysis | 2014 | 0 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K052078Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · 2 generations back · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
- K043147Achieva FamilyPhilips Medical Systems North America Co. · 2005 · 3 generations back · ◆ in the 2005 ancestors bar of FIG. 13 Class I recalls
- K041602Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 7 of the 15 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K141514 (Fujifilm Meidcal Systems U.S.A.,Inc., 2014) 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. 2012, 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?
Visia7 N Neuro is a medical image processing software application intended for the visualization of images from various sources such as Magnetic Resonance Imaging systems or from image archives. The system provides viewing, quantification, manipulation, communication, and printing of medical images. Visia TM Neuro provides both analysis and viewing capabilities for anatomical and physiologic/functional imaging datasets, including blood oxygen dependent…
Read the full statement (219 words)
Visia7 N Neuro is a medical image processing software application intended for the visualization of images from various sources such as Magnetic Resonance Imaging systems or from image archives. The system provides viewing, quantification, manipulation, communication, and printing of medical images. Visia TM Neuro provides both analysis and viewing capabilities for anatomical and physiologic/functional imaging datasets, including blood oxygen dependent (BOLD) fMRI, diffusion, fiber tracking, dynamic review, and vessel visualization. Data can be visualized in both 2D and 3D views.
BOLD fMRI Review
The BOLD ftvlRl feature is useful in identifying small susceptibility changes arising from neuronal activity during performance of a specific task.
Diffusion Review
The diffusion review feature is intended for visualization and analysis of the diffusion of water molecules through brain tissue.
Fiber Tracking Review
The fiber tracking feature uses the directional portion of the diffusion vector to track and visualize white matter structures within the brain.
Dynamic Review
Dynamic review feature is intended for visualization and analysis of MRI dynamic studies, showing changes in contrast over time, where such techniques are useful or necessary.
Vessel Visualization
The vessel feature is used to identify and visualize the vascular structures of the brain.
3D Visualization
The 3D visualization feature allows image data to be reconstructed as 3D objects that are visualized and manipulated on a 2D screen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113701 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113701: Visia Neuro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113701
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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