510(k) · Cleared
ClearedPVmed Contouring Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perception Vision Medical Technologies Ltd.Co. · LLZ System, Image Processing, Radiological
Cleared on Dec 3, 2021 as substantially equivalent to K173636 (Varian Medical Systems, Inc., 2018) after a 249-day review. Its family tree reaches back 13 generations to 1996.
- Decided
- Dec 3, 2021
- Review
- 249 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K954874 (1996). 72 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 13 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 9 generations between
- 3 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 2 generations backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- 1 generation backK173636 VelocityVarian Medical Systems, Inc. · 2018
- This deviceK210916 PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co. · 2021
Show all 13 generations
- Root · 13 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 12 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 11 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 10 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 9 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 8 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 7 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 6 generations backK062163 MimviewerMimvista Corp. · 2006
- 5 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 4 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 3 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 2 generations backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- 1 generation backK173636 VelocityVarian Medical Systems, Inc. · 2018
- This deviceK210916 PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −12 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −11 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −10 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −9 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −8 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −7 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −6 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −5 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −4 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −3 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| −2 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| −1 | K173636 | Velocity | Varian Medical Systems, Inc. | 2018 | — |
| 0 (this device) | K210916 | PVmed Contouring Software | Perception Vision Medical Technologies Ltd.Co. | 2021 | — |
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 |
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? (1)
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 |
|---|---|---|---|
| * | K173636 | VelocitySummary page 4…Item Predicate Device 510(k) Submitter/Holder Varian Medical Systems, Inc. 510(k) Number K173636 Device Name Velocity Medical image management and… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 18 of the 72 ancestors have a recall of any class.
- 3 other devices also cite its predicate K173636.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
PVmed Contouring Software is a software package. It allows the display, annotation, volume operation, volume rendering, and fusion of medical CT images as an aid during use by radiation therapy planning. it is limited to auto-contouring of OARs for head and neck, chest and abdomen, abdomen and pelvis.
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/K210916 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210916: PVmed Contouring Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210916
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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