510(k) · Cleared
ClearedVelocityais
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 Mar 1, 2007 as substantially equivalent to K010336 (Ge Medical Systems, Inc., 2001) and 2 other predicates after a 35-day review. Its family tree reaches back 8 generations to 1996. 65 later devices descend from it.
- Decided
- Mar 1, 2007
- Review
- 35 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K954874 (1996). 40 ancestors in all, the oldest K871859 (1987). 65 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 7 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 6 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 5 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 4 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 3 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 2 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 1 generation backK062163 MimviewerMimvista Corp. · 2006
- This deviceK070248 VelocityaisVelocity Medical Solutions, LLC · 2007
- Descendant · cites it directly · 63 of its ownK081076 Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC · 2008 · Recalled
- Descendant · 2 generations on · 36 of its ownK130393 Mirada RTXMirada Medical, Ltd. · 2013
- Descendant · 3 generations on · 25 of its ownK181572 Workflow BoxMirada Medical, Ltd. · 2018
- Descendant · 2 generations on · 13 of its ownK153014 Mobius3DMobius Medical Systems, LP · 2016
- Descendant · 2 generations on · 8 of its ownK173636 VelocityVarian Medical Systems, Inc. · 2018
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K081076Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC · 2008 · cites it directly63descendants
- K130393Mirada RTXMirada Medical, Ltd. · 2013 · 2 generations on36descendants
- K181572Workflow BoxMirada Medical, Ltd. · 2018 · 3 generations on25descendants
- K153014Mobius3DMobius Medical Systems, LP · 2016 · 2 generations on13descendants
- K173636VelocityVarian Medical Systems, Inc. · 2018 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −7 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −6 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −5 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −4 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −3 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −2 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −1 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| 0 (this device) | K070248 | Velocityais | Velocity Medical Solutions, LLC | 2007 | — |
| +1 | K081076 | Velocityais, Velocity AI, Velocityvx, Velocityrt, V-Response | Velocity Medical Solutions, LLC | 2008 | 1 |
| +2 | K130393 | Mirada RTX | Mirada Medical, Ltd. | 2013 | — |
| +3 | K181572 | Workflow Box | Mirada Medical, Ltd. | 2018 | — |
| +2 | K153014 | Mobius3D | Mobius Medical Systems, LP | 2016 | — |
| +2 | K173636 | Velocity | Varian Medical Systems, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K010336 | Advantage Windows CT/Pet FusionSummary page 1…ood, Drug and Cosmetic Act. 3. Predicate Device(s): GE Medical Systems, Advantage Windows CT/PET Fusion (K010336) GE Medical Systems, Volume Viewer Plus (K041521) MIMvista Corp., MIMviewer (K062163) 4. Description… | 2001 |
| * | K041521 | Volume Viewer PlusSummary page 1…Cosmetic Act. 3. Predicate Device(s): GE Medical Systems, Advantage Windows CT/PET Fusion (K010336) GE Medical Systems, Volume Viewer Plus (K041521) MIMvista Corp., MIMviewer (K062163) 4. Description of Device: VelocityAlS is a stand-alone software… | 2004 |
| * | K062163 | MimviewerSummary page 1…GE Medical Systems, Advantage Windows CT/PET Fusion (K010336) GE Medical Systems, Volume Viewer Plus (K041521) MIMvista Corp., MIMviewer (K062163) 4. Description of Device: VelocityAlS is a stand-alone software product that provides medical image processin… | 2006 |
What descends from it? (65)
See all 652 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 11 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 9 of the 40 ancestors have a recall of any class.
- Of its descendants, K081076 (Velocity Medical Solutions, LLC, 2008) has gone furthest, with 63 descendants of its own.
- 8 other devices also cite its predicate K010336.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
VelocityAlS 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. VelocityALS is not intended for mammography diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070248: Velocityais.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070248
Report an extraction error
Are you the manufacturer?
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