510(k) · Cleared
ClearedDC Neuro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invivo Corporation · LLZ System, Image Processing, Radiological
Cleared on Jun 17, 2008 as substantially equivalent to K052078 (Philips Medical Systems Nederland B.V., 2005) and 4 other predicates after a 43-day review. Its family tree reaches back 3 generations to 1991. 3 of the 17 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Jun 17, 2008
- Review
- 43 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K913475 (1991). 14 ancestors in all. 2 later devices descend from it, 1 citing it directly. 3 of the 17 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK913475 Magnetic Resonance Diagnostic DeviceGE Medical Systems · 1991
- 2 generations backK960265 Advantage Windows with Functool OptionGE Medical Systems · 1996 · Recalled
- 1 generation backK971965 Philips EasyvisionPhilips Medical Systems, Inc. · 1998
- This deviceK081262 DC NeuroInvivo Corporation · 2008
- Descendant · cites it directly · 1 of its ownK113701 Visia NeuroMeVis Medical Solutions AG · 2012
- Descendant · 2 generations on · 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913475 | Magnetic Resonance Diagnostic Device | GE Medical Systems | 1991 | — |
| −2 | K960265 | Advantage Windows with Functool Option | GE Medical Systems | 1996 | 1 |
| −1 | K971965 | Philips Easyvision | Philips Medical Systems, Inc. | 1998 | — |
| 0 (this device) | K081262 | DC Neuro | Invivo Corporation | 2008 | — |
| +1 | K113701 | Visia Neuro | MeVis Medical Solutions AG | 2012 | — |
| +2 | 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 |
|---|---|---|
| 2012 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K052078 | Achieva, Intera and Panorama 1.0 Release 2-SeriesSummary page 1…Submission Reference Diffusion / FiberTrak Philips Achieva, Intera, & Panorama 1LOT K052078 BOLD / fMRI Philips EasyVision Family Workstation K990329 Option - BOLD Anal… | 2005 |
| * | K990329 | Philips Easyvision WorkstationSummary page 1…Reference Diffusion / FiberTrak Philips Achieva, Intera, & Panorama 1LOT K052078 BOLD / fMRI Philips EasyVision Family Workstation K990329 Option - BOLD Analysis Package Dynamic Analysis, Philips Quantitative Analysis Package… | 1999 |
| * | K971965 | Philips EasyvisionSummary page 1…ion Family Workstation K990329 Option - BOLD Analysis Package Dynamic Analysis, Philips Quantitative Analysis Package K971965 Vessels Analysis 3D Rendering Philips EasyVision Family Workstation K953095… | 1998 |
| * | K953095 | Philips EasyvisionSummary page 1…ynamic Analysis, Philips Quantitative Analysis Package K971965 Vessels Analysis 3D Rendering Philips EasyVision Family Workstation K953095 Option - 3D Volume Rendering Image processing Philips View Forum… | 1995 |
| * | K032096 | Philips Viewforum 2003Summary page 1…ision Family Workstation K953095 Option - 3D Volume Rendering Image processing Philips View Forum K032096 workstation Page I of`3 === Page 2… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113701 | Visia Neuro | 2012 | 1 |
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 · Direct predicate · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
- K043147Achieva FamilyPhilips Medical Systems North America Co. · 2005 · 2 generations back · ◆ in the 2005 ancestors bar of FIG. 13 Class I recalls
- K041602Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · 2 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 7 of the 14 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K113701 (MeVis Medical Solutions AG, 2012) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K052078.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
DC Neuro is an image processing software package designed to run on standard PC hardware (workstation). The required workstation hardware consists of standard, "off-the-shelf" computer components. DC Neuro software receives image data from medical imaging devices such as Magnetic Resonance Imaging systems or from image archives, PACS. DC Neuro can be used to perform image viewing, image manipulation, image quantification, communication, and printing. DC…
Read the full statement (230 words)
DC Neuro is an image processing software package designed to run on standard PC hardware (workstation). The required workstation hardware consists of standard, "off-the-shelf" computer components. DC Neuro software receives image data from medical imaging devices such as Magnetic Resonance Imaging systems or from image archives, PACS. DC Neuro can be used to perform image viewing, image manipulation, image quantification, communication, and printing.
DC Neuro provides both analysis and viewing capabilities which integrate both anatomical and physiologic/functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, diffusion, fiber tracking, dynamic analysis, and vessel analysis in both 2D and/or 3D views.
BOLD fMRI: The BOLD analysis is useful in quantifying small susceptibility changes in the human brain, created by the execution of a specific task.
Diffusion/Fiber tracking: The diffusion of water molecules through brain tissue can be measured with diffusion-weighted MRI scanning. Actual diffusion properties depend on the local tissue. With fiber tracking, the directional dependency can be used to visualize the white matter structure in the brain.
Dynamic Analysis: Dynamic analysis is intended for visualization and analysis of MR dynamic studies, showing changes in contrast over time, where such techniques are useful or necessary.
Vessel Analysis: Allows the visualization of vascular morphology from MR images.
3D Visualization: 3D rendering allows the visualization of bone, vascular structures, and selected anatomy as three dimensional object surfaces projected on a flat screen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081262: DC Neuro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081262
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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