510(k) · Cleared
ClearedProKnow DS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Proknow, LLC · LLZ System, Image Processing, Radiological
Cleared on Jan 2, 2019 as substantially equivalent to K173636 (Varian Medical Systems, Inc., 2018) and 2 other predicates after an 84-day review. Its family tree reaches back 13 generations to 1996. 2 later devices descend from it.
- Decided
- Jan 2, 2019
- Review
- 84 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K954874 (1996). 73 ancestors in all, the oldest K871859 (1987). 2 later devices descend from it, 2 citing it directly.
- 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 deviceK182855 ProKnow DSProknow, LLC · 2019
- Descendant · cites it directly · 0 of its ownK251363 ProKnow DSElekta Solutions AB · 2025
- Descendant · cites it directly · 0 of its ownK193498 Infinitt RT PACSInfinitt Healthcare Co., Ltd. · 2020
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 deviceK182855 ProKnow DSProknow, LLC · 2019
Most influential descendants
Showing 2 of 2 · See allView 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) | K182855 | ProKnow DS | Proknow, LLC | 2019 | — |
| +1 | K251363 | ProKnow DS | Elekta Solutions AB | 2025 | — |
| +1 | K193498 | Infinitt RT PACS | Infinitt Healthcare Co., Ltd. | 2020 | — |
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 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K173636 | VelocitySummary page 4…rocessing, Radiological Regulation Number: 21 CFR 892.2050 Product Code: LLZ Regulatory Class: Class II Predicate Devices K173636 Velocity Varian Medical Systems, Inc. K101707 fullAccess Fulcrum… | 2018 |
| * | K101707 | Fulaccess Model 1.0Summary page 4…Code: LLZ Regulatory Class: Class II Predicate Devices K173636 Velocity Varian Medical Systems, Inc. K101707 fullAccess Fulcrum Medical, Inc. K071964 MIM 4.1 MIM Software, I… | 2010 |
| * | K071964 | Mim 4.1 (Seastar)Summary page 4…Predicate Devices K173636 Velocity Varian Medical Systems, Inc. K101707 fullAccess Fulcrum Medical, Inc. K071964 MIM 4.1 MIM Software, Inc. Device Description ProKnow DS is a Radiation Therapy Picture/Pati… | 2007 |
What descends from it? (2)
2 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 23 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 18 of the 73 ancestors have a recall of any class.
- Of its descendants, K251363 (Elekta Solutions AB, 2025) has gone furthest, with 0 descendants of its own.
- 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. 2019, 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?
ProKnow DS is a patient data archive, information management, and analytics software system with a focus on the data and images specific to radiation oncology patients. Users may upload digital patient data created by other devices to ProKnow DS to securely archive, display, and analyze the data. Users can view and navigate patient images, drawn anatomy, calculated dose, and plan details derived from the source files. Users can create or edit anatomy…
Read the full statement (206 words)
ProKnow DS is a patient data archive, information management, and analytics software system with a focus on the data and images specific to radiation oncology patients. Users may upload digital patient data created by other devices to ProKnow DS to securely archive, display, and analyze the data. Users can view and navigate patient images, drawn anatomy, calculated dose, and plan details derived from the source files. Users can create or edit anatomy structures to be used either prospectively (e.g., as an input to treatment planning) or retrospectively (e.g., for data analysis, research, and outcomes studies). Users can extract metrics for any single patient, or across a collection of patients, then view results as tables or graphically. ProKnow DS is to be used as an accessory system to perform data archive, review, and analysis, and is not to be used for diagnosis, treatment, or as the sole form of plan approval.
Users of ProKnow DS should be trained medical professionals including, but not limited to, radiologists, oncologists, physicians, medical technologists, dosimetrists, and physicians. Users should be familiar with the different sources of input data (such as images, structure sets, treatment plans, and calculated dose) as well as how to understand and interpret derived metrics (e.g., dose-volume histograms).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182855 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182855: ProKnow DS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182855
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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