510(k) · Cleared
Recalled · 2009Konrad, Model V.2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mrc Systems GmbH · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Oct 8, 2002 as substantially equivalent to K992434 (Nucletron Corp., 2000) after an 84-day review. Its family tree reaches back 3 generations to 1989. 20 later devices descend from it. It has been recalled once.
- Decided
- Oct 8, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K884261 (1989). 6 ancestors in all, the oldest K841997 (1984). 20 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK884261 Prowess 2000Small Systems Group, Inc. · 1989
- 2 generations backK940663 Peacock PlanNomos Corp. · 1996
- 1 generation backK992434 Itp, Model 1.0Nucletron Corp. · 2000
- This deviceK022307 Konrad, Model V.2.0Mrc Systems GmbH · 2002
- Descendant · cites it directly · 19 of its ownK061097 Coherence Dosimetrist, Model 2.2Siemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 18 of its ownK101119 Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 9 of its ownK151380 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2015
- Descendant · 3 generations on · 8 of its ownK162370 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2016
- Descendant · 3 generations on · 8 of its ownK151887 syngo VSimSiemens Medical Solutions USA, Inc. · 2015
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K061097Coherence Dosimetrist, Model 2.2Siemens Medical Solutions USA, Inc. · 2006 · cites it directly19descendants
- K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc. · 2010 · 2 generations on18descendants
- K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2015 · 3 generations on9descendants
- K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2016 · 3 generations on8descendants
- K151887syngo VSimSiemens Medical Solutions USA, Inc. · 2015 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K884261 | Prowess 2000 | Small Systems Group, Inc. | 1989 | — |
| −2 | K940663 | Peacock Plan | Nomos Corp. | 1996 | — |
| −1 | K992434 | Itp, Model 1.0 | Nucletron Corp. | 2000 | — |
| 0 (this device) | K022307 | Konrad, Model V.2.0 | Mrc Systems GmbH | 2002 | — |
| +1 | K061097 | Coherence Dosimetrist, Model 2.2 | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| +2 | K101119 | Syngo Dosimetrist Workspace V2.7 Model: 1056864 | Siemens Medical Solutions USA, Inc. | 2010 | 1 |
| +3 | K151380 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2015 | — |
| +3 | K162370 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2016 | — |
| +3 | K151887 | syngo VSim | Siemens Medical Solutions USA, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K992434 | Itp, Model 1.0Summary page 1…Manufacturer Device 510(k) # Nucletron PLAT0 ITP K992434 Appendix 5, page 2 Premarket No… | 2000 |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061097 | Coherence Dosimetrist, Model 2.2 | 2006 | 19 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 6, 2009 | Not classified | Z-1834-2011 | Software design | A problem in the software has the potential to be associated with the dose; when a template is created the user has the possibility to predefine organs. For the Target the user defines the max. dose and the min dose, for the OAR (Organs… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K061097 (Siemens Medical Solutions USA, Inc., 2006) has gone furthest, with 19 descendants of its own.
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?
KonRad is intended to optimize multi-leaf collimator (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (IMRT). Once the optimization is complete the dose distribution and dose volume histogram curves are displayed for the user to evaluate.
After approval the results are exported to the delivery equipment, Linear Accelerator or Record and Verify system, for final verification before treatment delivery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022307: Konrad, Model V.2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022307
Report an extraction error
Are you the manufacturer?
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