510(k) · Cleared
ClearedPlato Brachytheraphy, Model V. 14.0
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 Apr 2, 1999 as substantially equivalent to K911612 (Nucletron-Oldelft Corp., 1991) after a 191-day review. Its family tree reaches back 1 generation to 1991. 85 later devices descend from it.
- Decided
- Apr 2, 1999
- Review
- 191 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K911612 (1991). 85 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK911612 Nucletron Planning SystemNucletron-Oldelft Corp. · 1991
- This deviceK983343 Plato Brachytheraphy, Model V. 14.0Nucletron Corp. · 1999
- Descendant · cites it directly · 54 of its ownK081281 Ocentra Masterplan 3.1 (Ocentra Brachy)Nucletron Corporation · 2008 · Recalled
- Descendant · 2 generations on · 34 of its ownK092132 Xio RTP SystemComputerized Medical Systems, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 31 of its ownK083264 Rayautoplan 1.0Raysearch Laboratories AB · 2009 · Recalled
- Descendant · 2 generations on · 30 of its ownK100552 Raystation Version 1.0Raysearch Laboratories AB · 2010 · Recalled
- Descendant · 3 generations on · 27 of its ownK102216 Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · Recalled
Showing 5 of 85 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 85 · See all- K081281Ocentra Masterplan 3.1 (Ocentra Brachy)Nucletron Corporation · 2008 · cites it directly54descendants
- K092132Xio RTP SystemComputerized Medical Systems, Inc. · 2009 · 2 generations on34descendants
- K083264Rayautoplan 1.0Raysearch Laboratories AB · 2009 · 2 generations on31descendants
- K100552Raystation Version 1.0Raysearch Laboratories AB · 2010 · 2 generations on30descendants
- K102216Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · 3 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911612 | Nucletron Planning System | Nucletron-Oldelft Corp. | 1991 | — |
| 0 (this device) | K983343 | Plato Brachytheraphy, Model V. 14.0 | Nucletron Corp. | 1999 | — |
| +1 | K081281 | Ocentra Masterplan 3.1 (Ocentra Brachy) | Nucletron Corporation | 2008 | 2 |
| +2 | K092132 | Xio RTP System | Computerized Medical Systems, Inc. | 2009 | 12 |
| +2 | K083264 | Rayautoplan 1.0 | Raysearch Laboratories AB | 2009 | 2 |
| +2 | K100552 | Raystation Version 1.0 | Raysearch Laboratories AB | 2010 | 4 |
| +3 | K102216 | Xio RTP System | Computerized Medical Systems, Inc. | 2010 | 7 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 6 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 6 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K915562 | PLATO Brachytherapy Planning System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…bstantially equivalent to the legally marketed predicate devices cited in the table below. Manufacturer Device 510(k) # Nucletron BV PLATO Brachytherapy Planning System K915562 Nucletron BV Nucletron Planning System K911612 Appendix 5, page 2 Premarket Notification CO N Fl D E NTIAL Nucl… | |
| * | K911612 | Nucletron Planning SystemSummary page 1…predicate devices cited in the table below. Manufacturer Device 510(k) # Nucletron BV PLATO Brachytherapy Planning System K915562 Nucletron BV Nucletron Planning System K911612 Appendix 5, page 2 Premarket Notification CO N Fl D E NTIAL Nucletron PLATO Brachytherapy Date : 20 September 1… | 1991 |
What descends from it? (85)
See all 856 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081281 | Ocentra Masterplan 3.1 (Ocentra Brachy) | 2008 | 54 |
| K061152 | Mucheck V7.0 | 2006 | 21 |
| K121448 | Oncentra, Oncentra External Beam, Oncentra Brachy | 2012 | 9 |
| K081112 | Flexiplan Brachytherapy Treatment Planning System | 2008 | 3 |
| K030821 | Simuplan Treatment Planning System, Model V. 7.5 | 2003 | 2 |
| K113102 | Oncentra Manual Low Dose Rate Treatment Planning | 2011 | 0 |
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?
Brachytherapy planning with PLATO Brachytherapy is intended for use with brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal (including bronchlal) and surface applicator treatments, involving manual or remote afterloading radioactive sources. The software program provides the physician with anatomical and dosimetric information (i.e. radiographs, transverse slices, or 3D coordinates) to determine the positioning and loading of the…
Read the full statement (155 words)
Brachytherapy planning with PLATO Brachytherapy is intended for use with brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal (including bronchlal) and surface applicator treatments, involving manual or remote afterloading radioactive sources. The software program provides the physician with anatomical and dosimetric information (i.e. radiographs, transverse slices, or 3D coordinates) to determine the positioning and loading of the radioactive sources prior to insertion. The software also provides the treatment time and dose distribution for the specified loading. From this information the patient can be treated with radioactive sources.
With remote afterloading brachytherapy treatment planning the PLATO Brachytherapy program exports the treatment data, i.e. treatment times to the remote afterioader. With manual brachytherapy treatment planning the program exports treatment data regarding insertion/removal time, total dose in permanent implantation and dose distributions for patient records. With both types of software the dose grid is exported and can be evaluated in conjunction with the Nucletron PLATO External Beam treatment planning software.
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/K983343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983343: Plato Brachytheraphy, Model V. 14.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983343
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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