510(k) · Cleared
ClearedEvtool Model # V. 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3D Line USA, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jan 18, 2002 as substantially equivalent to K001163 (3D Line USA, Inc., 2000) after an 87-day review. Its family tree reaches back 1 generation to 2000. 30 later devices descend from it.
- Decided
- Jan 18, 2002
- Review
- 87 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001163 (2000). 30 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK001163 DMLC IV-Ergo3D Line USA, Inc. · 2000 · Recalled
- This deviceK013535 Evtool Model # V. 1.03D Line USA, Inc. · 2002
- Descendant · cites it directly · 29 of its ownK080601 Ergo++ Version 1.73D Line Medical Systems S.R.L. · 2008 · Recalled
- Descendant · 2 generations on · 13 of its ownK141572 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 12 of its ownK183034 MOSAIQ Oncology Information SystemElekta, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 12 of its ownK091179 Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc. · 2009 · Recalled
- Descendant · 4 generations on · 8 of its ownK203172 MOSAIQ Oncology Information SystemElekta Solutions AB · 2020 · Recalled
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K080601Ergo++ Version 1.73D Line Medical Systems S.R.L. · 2008 · cites it directly29descendants
- K141572Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2014 · 2 generations on13descendants
- K183034MOSAIQ Oncology Information SystemElekta, Inc. · 2018 · 3 generations on12descendants
- K091179Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc. · 2009 · 2 generations on12descendants
- K203172MOSAIQ Oncology Information SystemElekta Solutions AB · 2020 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001163 | DMLC IV-Ergo | 3D Line USA, Inc. | 2000 | 3 |
| 0 (this device) | K013535 | Evtool Model # V. 1.0 | 3D Line USA, Inc. | 2002 | — |
| +1 | K080601 | Ergo++ Version 1.7 | 3D Line Medical Systems S.R.L. | 2008 | 2 |
| +2 | K141572 | Mosaiq Oncology Information System | Impac Medical Systems, Inc. | 2014 | 11 |
| +3 | K183034 | MOSAIQ Oncology Information System | Elekta, Inc. | 2018 | 2 |
| +2 | K091179 | Monaco RTP System, Vmat Option | Computerized Medical Systems, Inc. | 2009 | 5 |
| +4 | K203172 | MOSAIQ Oncology Information System | Elekta Solutions AB | 2020 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K001163 | DMLC IV-ErgoSummary page 1…Device(s) Our device is substantially equivalent to the legally marketed predicate devices cited in the table below. Manufacturer Device 510(k) # 3D Line DMLC IV-ERGO K001163 d. Description EVTOOL is a software module that has been designed to expand the features and functions of the DMLC IV- ERGO tre… | 2000 |
What descends from it? (30)
See all 301 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080601 | Ergo++ Version 1.7 | 2008 | 29 |
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?
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.
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?
EVTOOL software module provides the ability to compare and evaluate the radiation dose delivery to the tumor volume and surrounding organs from generated dose volume histograms and radiobiological values. It expands the DMLC IV-ERGO system, which is a combination of a radiation collimator with multiple tungsten leaves that move during delivery of radiation therapy and a computer based treatment planning and control system.
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/K013535 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013535: Evtool Model # V. 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013535
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026