510(k) · Cleared
ClearedVelocity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 15, 2018 as substantially equivalent to K081076 (Velocity Medical Solutions, LLC, 2008) and 1 other predicate after an 83-day review. Its family tree reaches back 12 generations to 1996. 8 later devices descend from it.
- Decided
- Feb 15, 2018
- Review
- 83 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K954874 (1996). 71 ancestors in all, the oldest K871859 (1987). 8 later devices descend from it, 4 citing it directly.
- Root · 12 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 8 generations between
- 3 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 2 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 1 generation backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- This deviceK173636 VelocityVarian Medical Systems, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK182855 ProKnow DSProknow, LLC · 2019
- Descendant · cites it directly · 1 of its ownK191610 RTappSegana, LLC · 2019
- Descendant · cites it directly · 1 of its ownK182966 PLANET Onco DoseDosisoft · 2019
- Descendant · 2 generations on · 0 of its ownK251363 ProKnow DSElekta Solutions AB · 2025
- Descendant · 2 generations on · 0 of its ownK241765 PLANET Onco Dose (3.2)Dosisoft SA · 2025
Show all 12 generations
- Root · 12 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 11 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 10 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 9 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 8 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 7 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 6 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 5 generations backK062163 MimviewerMimvista Corp. · 2006
- 4 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 3 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 2 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 1 generation backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- This deviceK173636 VelocityVarian Medical Systems, Inc. · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K182855ProKnow DSProknow, LLC · 2019 · cites it directly2descendants
- K191610RTappSegana, LLC · 2019 · cites it directly1descendant
- K182966PLANET Onco DoseDosisoft · 2019 · cites it directly1descendant
- K251363ProKnow DSElekta Solutions AB · 2025 · 2 generations on0descendants
- K241765PLANET Onco Dose (3.2)Dosisoft SA · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −11 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −10 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −9 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −8 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −7 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −6 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −5 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −4 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −3 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −2 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| −1 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| 0 (this device) | K173636 | Velocity | Varian Medical Systems, Inc. | 2018 | — |
| +1 | K182855 | ProKnow DS | Proknow, LLC | 2019 | — |
| +1 | K191610 | RTapp | Segana, LLC | 2019 | — |
| +1 | K182966 | PLANET Onco Dose | Dosisoft | 2019 | — |
| +2 | K251363 | ProKnow DS | Elekta Solutions AB | 2025 | — |
| +2 | K241765 | PLANET Onco Dose (3.2) | Dosisoft SA | 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 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2025 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K081076 | Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseSummary page 4…uct Code: LLZ Common/Usual Name: Picture Archiving and Communication System (Medical Imaging Software) Predicate Devices: Primary predicate: Velocity AI – K081076 Secondary predicate: MIM Y90 Dosimetry - K172218 Device Description: Velocity is a software appli… | 2008 |
| * | K172218 | MIM – Y90 DosimetrySummary page 4…n System (Medical Imaging Software) Predicate Devices: Primary predicate: Velocity AI – K081076 Secondary predicate: MIM Y90 Dosimetry - K172218 Device Description: Velocity is a software application providing relevant tools for Radiotherapy… | 2017 |
What descends from it? (8)
4 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 22 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 18 of the 71 ancestors have a recall of any class.
- Of its descendants, K182855 (Proknow, LLC, 2019) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K081076.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Velocity is a software package that provides the physicians a means for comparison of medical data including imaging data that is DICOM compliant. It allows the display, annotation, volume operation, volume rendering, registration, and fusion of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties. Velocity is not intended for mammography.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173636: Velocity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173636
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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