510(k) · Cleared
ClearedDose Volume Histogram (DVH) Evaluator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diversilabs, LLC · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Dec 16, 2009 as substantially equivalent to K000478 (Accuray, Inc., 2000) and 1 other predicate after an 84-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Dec 16, 2009
- Review
- 84 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K010975 (2001). 12 ancestors in all, the oldest K992762 (2000). No later device cites it as a predicate yet.
- Root · 7 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 6 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 5 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 4 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 3 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 2 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 1 generation backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- This deviceK092928 Dose Volume Histogram (DVH) EvaluatorDiversilabs, LLC · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −6 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −5 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −4 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −3 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −2 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −1 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| 0 (this device) | K092928 | Dose Volume Histogram (DVH) Evaluator | Diversilabs, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 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 MUJ? 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 MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 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 |
|---|---|---|---|
| * | K000478 | The Cyberknife System for Stereotactic Radiosurgery/ Radiotherapy V2.1Summary page 2…Predicate510(k) Predicate Equivalent Devices: Model Number Manufacturer/ Model1 Dose Volume K000478 Accuray, Inc MultiPlan v2. 1 Histogram (DVH) Radiation Treatment… | 2000 |
| * | K091492 | Modification to Eclipse Treatment Planning SystemSummary page 2…Radiation Treatment Evaluator Planning System K09 1492 Varian Medical Systems, Inc. Eclipse Treatment… | 2009 |
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 8 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 12 ancestors have a recall of any class.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, 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 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
The DiversiLabs Dose Volume Histogram (DVH) Evaluator is intended to aid with comparing radiation therapy treatment plans to applicable dose tolerance limits, and for recording followup patient response and symptoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092928 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092928: Dose Volume Histogram (DVH) Evaluator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092928
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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