510(k) · Cleared
ClearedEZFluence (RADEZ V2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radformation, Inc. · IYE Accelerator, Linear, Medical
Cleared on Aug 31, 2026 as substantially equivalent to K171352 (Radformation, Inc., 2017) after a 97-day review. Its family tree reaches back 13 generations to 2001.
- Decided
- Aug 31, 2026
- Review
- 97 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K010975 (2001). 17 ancestors in all, the oldest K992762 (2000). No later device cites it as a predicate yet.
- Root · 13 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 9 generations between
- 3 generations backK141283 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014 · Recalled
- 2 generations backK152393 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2015 · Recalled
- 1 generation backK171352 EZFluenceRadformation, Inc. · 2017
- This deviceK261718 EZFluence (RADEZ V2)Radformation, Inc. · 2026
Show all 13 generations
- Root · 13 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 12 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 11 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 10 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 9 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 8 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 7 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 6 generations backK102011 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · Recalled
- 5 generations backK131891 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2013
- 4 generations backK133247 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014
- 3 generations backK141283 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014 · Recalled
- 2 generations backK152393 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2015 · Recalled
- 1 generation backK171352 EZFluenceRadformation, Inc. · 2017
- This deviceK261718 EZFluence (RADEZ V2)Radformation, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −12 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −11 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −10 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −9 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −8 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −7 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −6 | K102011 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2010 | 5 |
| −5 | K131891 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2013 | — |
| −4 | K133247 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | — |
| −3 | K141283 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | 1 |
| −2 | K152393 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2015 | 1 |
| −1 | K171352 | EZFluence | Radformation, Inc. | 2017 | — |
| 0 (this device) | K261718 | EZFluence (RADEZ V2) | Radformation, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 3 | 0 |
| 2002 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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 |
|---|---|---|---|
| * | K171352 | EZFluenceSummary page 6…== Page 6 === 3. Predicate Device and Reference Device Information Predicate Device EZFluence (RADEZ V2) (Subject Device) makes use of its prior submission - EZFluence (K171352) - as the primary Predicate Device. The Indications for Use, patient population, functionality and technical components of this P… | 2017 |
| † | K200608 | Eclipse Treatment Planning System v16.0 | 2020 |
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 3 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 17 ancestors have a recall of any class.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
EZFluence (RADEZ V2) is intended to assist radiation treatment planning professionals in generating
optimal fluences for producing a homogeneous dose distribution in external beam radiation therapy
treatment plans consisting of photon treatment fields.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261718: EZFluence (RADEZ V2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261718
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026