510(k) · Cleared
Recalled · Class II · 2017Ergo++ Version 1.7
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3D Line Medical Systems S.R.L. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jun 6, 2008 as substantially equivalent to K001163 (3D Line USA, Inc., 2000) and 2 other predicates after a 95-day review. Its family tree reaches back 2 generations to 2000. 29 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 6, 2008
- Review
- 95 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 2 generations to K001163 (2000). 4 ancestors in all. 29 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK001163 DMLC IV-Ergo3D Line USA, Inc. · 2000 · Recalled
- 1 generation backK013535 Evtool Model # V. 1.03D Line USA, Inc. · 2002
- This deviceK080601 Ergo++ Version 1.73D Line Medical Systems S.R.L. · 2008
- Descendant · cites it directly · 13 of its ownK141572 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 12 of its ownK183034 MOSAIQ Oncology Information SystemElekta, Inc. · 2018 · Recalled
- Descendant · cites it directly · 12 of its ownK091179 Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 8 of its ownK203172 MOSAIQ Oncology Information SystemElekta Solutions AB · 2020 · Recalled
- Descendant · cites it directly · 8 of its ownK110730 Monaco RTP SystemComputerized Medical Systems, Inc. · 2011 · Recalled
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K141572Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2014 · cites it directly13descendants
- K183034MOSAIQ Oncology Information SystemElekta, Inc. · 2018 · 2 generations on12descendants
- K091179Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc. · 2009 · cites it directly12descendants
- K203172MOSAIQ Oncology Information SystemElekta Solutions AB · 2020 · 3 generations on8descendants
- K110730Monaco RTP SystemComputerized Medical Systems, Inc. · 2011 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001163 | DMLC IV-Ergo | 3D Line USA, Inc. | 2000 | 3 |
| −1 | K013535 | Evtool Model # V. 1.0 | 3D Line USA, Inc. | 2002 | — |
| 0 (this device) | K080601 | Ergo++ Version 1.7 | 3D Line Medical Systems S.R.L. | 2008 | — |
| +1 | K141572 | Mosaiq Oncology Information System | Impac Medical Systems, Inc. | 2014 | 11 |
| +2 | K183034 | MOSAIQ Oncology Information System | Elekta, Inc. | 2018 | 2 |
| +1 | K091179 | Monaco RTP System, Vmat Option | Computerized Medical Systems, Inc. | 2009 | 5 |
| +3 | K203172 | MOSAIQ Oncology Information System | Elekta Solutions AB | 2020 | 1 |
| +1 | K110730 | Monaco RTP System | Computerized Medical Systems, Inc. | 2011 | 6 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K001163 | DMLC IV-ErgoSummary page 2…* date the summary was prepared: February, 28 th 2008 · A statement of substantial equivalence to ERGO, ERGO SRS and ERGO EVTOOL (3D Line USA, Inc) (K001163, K031281, K013535) manufactured by 3D Line USA, Inc is Appendix 7 of this notification. * description of the devi… | 2000 |
| * | K031281 | Ergo SRSSummary page 1…hereby submits this Traditional 510(k) for our ERGO++ Treatment Planning System. ERGO++ is a modification of ERGO, ERGO SRS and ERGO EVTOOL (3D Line USA, Inc) (KOO1 163, K031281, K013535). The modifications are listed in Appendix 8. We believe these modifications are not eligible for the Special 510 (k) pr… | 2003 |
| * | K013535 | Evtool Model # V. 1.0Summary page 1…bmits this Traditional 510(k) for our ERGO++ Treatment Planning System. ERGO++ is a modification of ERGO, ERGO SRS and ERGO EVTOOL (3D Line USA, Inc) (KOO1 163, K031281, K013535). The modifications are listed in Appendix 8. We believe these modifications are not eligible for the Special 510 (k) process. W… | 2002 |
What descends from it? (29)
See all 296 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 1, 2017 | Class II | Z-0234-2018 | Nonconforming Material/Component | Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect rotation of the collimator or couch when using a MLC device for planning. |
| Dec 11, 2009 | Not classified | Z-2645-2011 | Software design | ERGO Release 1.6.3 is overestimating the MU values. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K141572 (Impac Medical Systems, Inc., 2014) has gone furthest, with 13 descendants of its own.
- 4 other devices also cite its predicate K001163.
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. 2008, 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?
ERGO++ is a treatment planning system. It is an accessory to linear accelerators used for radiation therapy. It is indicated for-use in the planning of 3 dimensional radiation therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080601 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080601: Ergo++ Version 1.7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080601
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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