510(k) Report

510(k) · Cleared

Cleared

Velocity

K173636510(k) TraditionalCleared Feb 15, 201883-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2011: 1 other ancestor2007: 2 other ancestors2004: 6 other ancestors2001: 7 other ancestors2006: 1 other ancestor2005: 2 other ancestors2003: 3 other ancestors2000: 5 other ancestors1997: 3 other ancestors2002: 3 other ancestors1998: 3 other ancestors1995: 4 other ancestors1993: 3 other ancestors1987: 1 other ancestor1999: 1 other ancestor1994: 2 other ancestors1992: 2 other ancestors1996: 3 other ancestors1991: 4 other ancestors1990: 1 other ancestor1989: 1 other ancestor2021: 2 descendants cleared2019: 3 descendants cleared2020: 1 descendant cleared2025: 2 descendants clearedK954874 · Spectef Protocol · GE Medical Systems · 1996K980914 · Emory Cardiac Tool Box · Emory University · 1998K992450 · Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers · Emory University · 1999K014033 · Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers · Syntermed, Inc. · 2002K040141 · Emory Cardiac Toolbox Version 2.6 · Syntermed, Inc. · 2004K052379 · Mim 3.5 (Circa) · Mimvista Corp. · 2005×2: 2 generations cleared close together, K060816 (2006), K062163 (2006) K103785 · Mobile Mim · Mim Software, Inc. · 2011K112930 · Mobile Mim · Mim Software, Inc. · 2011K151913 · MIM-Thin Client (mobile) · Mim Software, Inc. · 2016K172218 · MIM – Y90 Dosimetry · Mim Software, Inc. · 20171990200020102020
  1. Root · 12 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
  2. 8 generations between
  3. 3 generations backK112930 Mobile MimMim Software, Inc. · 2011
  4. 2 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
  5. 1 generation backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
  6. This deviceK173636 VelocityVarian Medical Systems, Inc. · 2018
  7. Descendant · cites it directly · 2 of its ownK182855 ProKnow DSProknow, LLC · 2019
  8. Descendant · cites it directly · 1 of its ownK191610 RTappSegana, LLC · 2019
  9. Descendant · cites it directly · 1 of its ownK182966 PLANET Onco DoseDosisoft · 2019
  10. Descendant · 2 generations on · 0 of its ownK251363 ProKnow DSElekta Solutions AB · 2025
  11. Descendant · 2 generations on · 0 of its ownK241765 PLANET Onco Dose (3.2)Dosisoft SA · 2025
Show all 12 generations
  1. Root · 12 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
  2. 11 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
  3. 10 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
  4. 9 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
  5. 8 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
  6. 7 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
  7. 6 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
  8. 5 generations backK062163 MimviewerMimvista Corp. · 2006
  9. 4 generations backK103785 Mobile MimMim Software, Inc. · 2011
  10. 3 generations backK112930 Mobile MimMim Software, Inc. · 2011
  11. 2 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
  12. 1 generation backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
  13. This deviceK173636 VelocityVarian Medical Systems, Inc. · 2018

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2019: 32020: 12021: 22025: 2
2019high 3 (2019) · low 0 (2022)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
−12K954874Spectef ProtocolGE Medical Systems1996—
−11K980914Emory Cardiac Tool BoxEmory University1998—
−10K992450Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University1999—
−9K014033Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc.2002—
−8K040141Emory Cardiac Toolbox Version 2.6Syntermed, Inc.2004—
−7K052379Mim 3.5 (Circa)Mimvista Corp.2005—
−6K060816Mim 4.0 (NeuroMimvista Corp.20061
−5K062163MimviewerMimvista Corp.2006—
−4K103785Mobile MimMim Software, Inc.2011—
−3K112930Mobile MimMim Software, Inc.2011—
−2K151913MIM-Thin Client (mobile)Mim Software, Inc.2016—
−1K172218MIM – Y90 DosimetryMim Software, Inc.2017—
0 (this device)K173636VelocityVarian Medical Systems, Inc.2018—
+1K182855ProKnow DSProknow, LLC2019—
+1K191610RTappSegana, LLC2019—
+1K182966PLANET Onco DoseDosisoft2019—
+2K251363ProKnow DSElekta Solutions AB2025—
+2K241765PLANET Onco Dose (3.2)Dosisoft SA2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198910
199010
199140
199220
199330
199420
199540
199630
199730
199830
199910
200050
200170
200230
200330
200460
200520
200610
200720
200810
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201930
202010
202120
202520
FIG. 1 — Lineage of K173636, 1996–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K081076Velocityais, Velocity AI, Velocityvx, Velocityrt, V-Response
Summary 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…
Velocity Medical Solutions, LLC20081
*K172218MIM – Y90 Dosimetry
Summary 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…
Mim Software, Inc.2017—

Also cleared against K081076: 5 other devices →

What descends from it? (8)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K182855ProKnow DSProknow, LLC20192
K191610RTappSegana, LLC20191
K182966PLANET Onco DoseDosisoft20191
K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210

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 devices

LLZ 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

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

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.

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