510(k) · Cleared
ClearedPlato Brachytheraphy Treatment Planning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nucletron-Oldelft Corp. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Sep 25, 1992 after a 284-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 26 later devices descend from it.
- Decided
- Sep 25, 1992
- Review
- 284 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 1 citing it directly.
- This deviceK915622 Plato Brachytheraphy Treatment Planning SystemNucletron-Oldelft Corp. · 1992
- Descendant · cites it directly · 25 of its ownK962892 Helax TMS Brachytherapy, Version 3.0Siemens Medical Solutions USA, Inc. · 1996
- Descendant · 2 generations on · 24 of its ownK993766 Helax-TMS V 5.0 Radiation Therapy Treatment Planning SystemHelax AB · 1999
- Descendant · 2 generations on · 23 of its ownK010682 Helax-TMS V 5.1 Radiation Therapy Treatment Planning SystemMds Nordion · 2001
- Descendant · 3 generations on · 22 of its ownK020971 DCM 2.0Mds Nordion AB · 2002
- Descendant · 4 generations on · 21 of its ownK130617 RaystationRaysearch Laboratories AB · 2013 · Recalled
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K962892Helax TMS Brachytherapy, Version 3.0Siemens Medical Solutions USA, Inc. · 1996 · cites it directly25descendants
- K993766Helax-TMS V 5.0 Radiation Therapy Treatment Planning SystemHelax AB · 1999 · 2 generations on24descendants
- K010682Helax-TMS V 5.1 Radiation Therapy Treatment Planning SystemMds Nordion · 2001 · 2 generations on23descendants
- K020971DCM 2.0Mds Nordion AB · 2002 · 3 generations on22descendants
- K130617RaystationRaysearch Laboratories AB · 2013 · 4 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915622 | Plato Brachytheraphy Treatment Planning System | Nucletron-Oldelft Corp. | 1992 | — |
| +1 | K962892 | Helax TMS Brachytherapy, Version 3.0 | Siemens Medical Solutions USA, Inc. | 1996 | — |
| +2 | K993766 | Helax-TMS V 5.0 Radiation Therapy Treatment Planning System | Helax AB | 1999 | — |
| +2 | K010682 | Helax-TMS V 5.1 Radiation Therapy Treatment Planning System | Mds Nordion | 2001 | — |
| +3 | K020971 | DCM 2.0 | Mds Nordion AB | 2002 | — |
| +4 | K130617 | Raystation | Raysearch Laboratories AB | 2013 | 6 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JAQ? 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 JAQ device
- #1 K241853 Titanium Fletcher-Style Applicator Set Defined…score 14.9 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962892 | Helax TMS Brachytherapy, Version 3.0 | 1996 | 25 |
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?
- Of its descendants, K962892 (Siemens Medical Solutions USA, Inc., 1996) has gone furthest, with 25 descendants of its own.
How does its category compare?
All JAQ devicesJAQ System, Applicator, Radionuclide, Remote-Controlled: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAQ
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAQ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAQ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAQ
3in 2025
MAUDE reports naming product code JAQ, 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 | 11 | 48 | 0 | 13 |
| 2008 | 10 | 34 | 5 | 32 |
| 2009 | 10 | 27 | 1 | 35 |
| 2010 | 2 | — | 2 | 36 |
| 2011 | 2 | — | 13 | 42 |
| 2012 | 7 | 89 | 5 | 34 |
| 2013 | 6 | 100 | 1 | 43 |
| 2014 | 7 | 116 | 0 | 18 |
| 2015 | 11 | 183 | 0 | 7 |
| 2016 | 6 | 154 | 0 | 3 |
| 2017 | 7 | 229 | 0 | 5 |
| 2018 | 7 | 252 | 0 | 2 |
| 2019 | 2 | — | 1 | 8 |
| 2020 | 4 | 62 | 0 | 8 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 2 | — | 0 | 3 |
| 2024 | 10 | 126 | 0 | 1 |
| 2025 | 6 | 91 | 0 | 3 |
| 2026 | 2 | — | 3 | — |
https://510kreport.com/device/K915622 · printed Nov 6, 2026
Cite this page
510(k) Report. “K915622: Plato Brachytheraphy Treatment Planning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915622
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026