510(k) · Cleared
ClearedTreatment Control Station - Microselectron-HDR Classic Upgrade, Version 1.20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nucletron Corp. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Apr 2, 1999 as substantially equivalent to K864210 (Nucletron-Oldelft Corp., 1986) and 1 other predicate after a 210-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Apr 2, 1999
- Review
- 210 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K864210 (1986). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −1 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| 0 (this device) | K983115 | Treatment Control Station - Microselectron-HDR Classic Upgrade, Version 1.20 | Nucletron Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K864210 | Microselectron-HDR (High Dose Rate)Summary page 2…NH [d003 Premarket Notification Nucletron microSelectron-HDR classic with TCS Date : 31 August, 1998 Manufacturer Device 510(k) # Nucletron microSelectron-HDR classic K864210 Nucletron microSelectron-HDR K953946 Descriptlion The Treatment Control Station (TCS) described in this submission is a softwar… | 1986 |
| * | K953946 | Microselectron-HDR Version 2Summary page 2…tron microSelectron-HDR classic with TCS Date : 31 August, 1998 Manufacturer Device 510(k) # Nucletron microSelectron-HDR classic K864210 Nucletron microSelectron-HDR K953946 Descriptlion The Treatment Control Station (TCS) described in this submission is a software and hardware package which replaces… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 2 companies; a new generation was cleared every 9.7 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K864210.
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 | — |
What is it indicated for?
Remote Afterloading Brachytherapy Unit for interstitial, intracavitary, intraluminal, including bronchial, endovascular (PARIS IDE), intraoperative and surface applicator treatments.
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/K983115 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983115: Treatment Control Station - Microselectron-HDR Classic Upgrade, Version 1.20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983115
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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