510(k) · Cleared
Recalled · Class II · 2013Velocityais, Velocity AI, Velocityvx, Velocityrt, V-Response
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Velocity Medical Solutions, LLC · LLZ System, Image Processing, Radiological
Cleared on Jun 20, 2008 as substantially equivalent to K070248 (Velocity Medical Solutions, LLC, 2007) and 3 other predicates after a 65-day review. Its family tree reaches back 9 generations to 1996. 63 later devices descend from it. It has been recalled once.
- Decided
- Jun 20, 2008
- Review
- 65 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 9 generations to K954874 (1996). 56 ancestors in all, the oldest K871859 (1987). 63 later devices descend from it, 6 citing it directly.
- Root · 9 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 5 generations between
- 3 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 2 generations backK062163 MimviewerMimvista Corp. · 2006
- 1 generation backK070248 VelocityaisVelocity Medical Solutions, LLC · 2007
- This deviceK081076 Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC · 2008
- Descendant · cites it directly · 36 of its ownK130393 Mirada RTXMirada Medical, Ltd. · 2013
- Descendant · 2 generations on · 25 of its ownK181572 Workflow BoxMirada Medical, Ltd. · 2018
- Descendant · cites it directly · 13 of its ownK153014 Mobius3DMobius Medical Systems, LP · 2016
- Descendant · cites it directly · 8 of its ownK173636 VelocityVarian Medical Systems, Inc. · 2018
- Descendant · 2 generations on · 8 of its ownK132045 Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft · 2013
Show all 9 generations
- Root · 9 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 8 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 7 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 6 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 5 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 4 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 3 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 2 generations backK062163 MimviewerMimvista Corp. · 2006
- 1 generation backK070248 VelocityaisVelocity Medical Solutions, LLC · 2007
- This deviceK081076 Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC · 2008
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K130393Mirada RTXMirada Medical, Ltd. · 2013 · cites it directly36descendants
- K181572Workflow BoxMirada Medical, Ltd. · 2018 · 2 generations on25descendants
- K153014Mobius3DMobius Medical Systems, LP · 2016 · cites it directly13descendants
- K173636VelocityVarian Medical Systems, Inc. · 2018 · cites it directly8descendants
- K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft · 2013 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −8 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −7 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −6 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −5 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −4 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −3 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −2 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −1 | K070248 | Velocityais | Velocity Medical Solutions, LLC | 2007 | — |
| 0 (this device) | K081076 | Velocityais, Velocity AI, Velocityvx, Velocityrt, V-Response | Velocity Medical Solutions, LLC | 2008 | — |
| +1 | K130393 | Mirada RTX | Mirada Medical, Ltd. | 2013 | — |
| +2 | K181572 | Workflow Box | Mirada Medical, Ltd. | 2018 | — |
| +1 | K153014 | Mobius3D | Mobius Medical Systems, LP | 2016 | — |
| +1 | K173636 | Velocity | Varian Medical Systems, Inc. | 2018 | — |
| +2 | K132045 | Advantagesim MD with CT Atlas-Based Contouring and RE-Planning Options | Ge Hungary Kft | 2013 | — |
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 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 8 | 0 |
| 2022 | 7 | 0 |
| 2023 | 8 | 0 |
| 2024 | 4 | 0 |
| 2025 | 7 | 0 |
| 2026 | 8 | 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? (4)
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 |
|---|---|---|---|
| * | K070248 | VelocityaisSummary page 1…section 513(b) of the Food, Drug and Cosmetic Act. 3. Predicate Device(s): Velocity Medical Solutions, VelocityAIS (K070248) GE Medical Systems, Advantage Windows CT/PET Fusion (KO10336) GE Medical Systems, Volume Viewer Plus (K041521) MI… | 2007 |
| * | K010336 | Advantage Windows CT/Pet Fusion | 2001 |
| * | K041521 | Volume Viewer PlusSummary page 1…: Velocity Medical Solutions, VelocityAIS (K070248) GE Medical Systems, Advantage Windows CT/PET Fusion (KO10336) GE Medical Systems, Volume Viewer Plus (K041521) MIMvista Corp., MIMVista (K071964) 4. Description of Device: Version 2.0 of VelocityAIS, also marketed as Velocity… | 2004 |
| * | K071964 | Mim 4.1 (Seastar)Summary page 1…cityAIS (K070248) GE Medical Systems, Advantage Windows CT/PET Fusion (KO10336) GE Medical Systems, Volume Viewer Plus (K041521) MIMvista Corp., MIMVista (K071964) 4. Description of Device: Version 2.0 of VelocityAIS, also marketed as VelocityAI with this version, is a stand-alone… | 2007 |
What descends from it? (63)
See all 636 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 |
|---|---|---|---|---|
| Jul 25, 2013 | Class II | Z-1275-2014 | Software design | An anomaly was detected such that, under certain conditions, a summed dose created by Velocity replaces the calculated dose from an approved plan in Eclipse when importing the dose from Velocity. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 14 of the 56 ancestors have a recall of any class.
- Of its descendants, K130393 (Mirada Medical, Ltd., 2013) has gone furthest, with 36 descendants of its own.
- 1 other device also cites its predicate K070248.
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?
VelocityAIS (VelocityAI) is a stand-alone software product that provides the physician a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties. VelocityAIS (VelocityAl) is not intended for mammography diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081076 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081076: Velocityais, Velocity AI, Velocityvx, Velocityrt, V-Response.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081076
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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