510(k) · Cleared
ClearedItp, Model 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nucletron Corp. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jan 13, 2000 as substantially equivalent to K940663 (Nomos Corp., 1996) and 1 other predicate after a 176-day review. Its family tree reaches back 2 generations to 1989. 21 later devices descend from it.
- Decided
- Jan 13, 2000
- Review
- 176 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K884261 (1989). 5 ancestors in all, the oldest K841997 (1984). 21 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK884261 Prowess 2000Small Systems Group, Inc. · 1989
- 1 generation backK940663 Peacock PlanNomos Corp. · 1996
- This deviceK992434 Itp, Model 1.0Nucletron Corp. · 2000
- Descendant · cites it directly · 20 of its ownK022307 Konrad, Model V.2.0Mrc Systems GmbH · 2002 · Recalled
- Descendant · 2 generations on · 19 of its ownK061097 Coherence Dosimetrist, Model 2.2Siemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 18 of its ownK101119 Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc. · 2010 · Recalled
- Descendant · 4 generations on · 9 of its ownK151380 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2015
- Descendant · 4 generations on · 8 of its ownK162370 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2016
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K022307Konrad, Model V.2.0Mrc Systems GmbH · 2002 · cites it directly20descendants
- K061097Coherence Dosimetrist, Model 2.2Siemens Medical Solutions USA, Inc. · 2006 · 2 generations on19descendants
- K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc. · 2010 · 3 generations on18descendants
- K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2015 · 4 generations on9descendants
- K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2016 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K884261 | Prowess 2000 | Small Systems Group, Inc. | 1989 | — |
| −1 | K940663 | Peacock Plan | Nomos Corp. | 1996 | — |
| 0 (this device) | K992434 | Itp, Model 1.0 | Nucletron Corp. | 2000 | — |
| +1 | K022307 | Konrad, Model V.2.0 | Mrc Systems GmbH | 2002 | 1 |
| +2 | K061097 | Coherence Dosimetrist, Model 2.2 | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| +3 | K101119 | Syngo Dosimetrist Workspace V2.7 Model: 1056864 | Siemens Medical Solutions USA, Inc. | 2010 | 1 |
| +4 | K151380 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2015 | — |
| +4 | K162370 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2016 | — |
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 |
|---|---|---|
| 2002 | 1 | 0 |
| 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K940663 | Peacock PlanSummary page 1…ce(s) Qur device is substantially equivalent to the legally marketed predicate devices cited in the table below. Manufacturer Device 510(k) # NOMOS Corp. Peacock Plan K940663 General Electric | Target Series 2 K841997 Nucletron PLATO RTS K3864206 Appendix 5, page 2 Premarket Notificatio… | 1996 |
| * | K841997 | CT 9800Summary page 1…nt to the legally marketed predicate devices cited in the table below. Manufacturer Device 510(k) # NOMOS Corp. Peacock Plan K940663 General Electric | Target Series 2 K841997 Nucletron PLATO RTS K3864206 Appendix 5, page 2 Premarket Notification / <9qg /7[347( Nucletron Inverse Treatme… | 1984 |
| Kept off the family tree | K986420 | Plato RTS Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022307 | Konrad, Model V.2.0 | 2002 | 20 |
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 11 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K022307 (Mrc Systems GmbH, 2002) has gone furthest, with 20 descendants of its own.
- 6 other devices also cite its predicate K940663.
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?
PLATO ITP is intendad to optimizo multi lcaf collimator (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (IMRT) prior to final dosimetry planning on PLATO RTS extemal beam planning.
Once the optimization is complete, the dose distribution and dnce-volume histogram curves are displayed for the user to evaluate. The optimized plan can be saved for final dose calculation and plan output using PLATO RTS.
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/K992434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992434: Itp, Model 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992434
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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