510(k) · Cleared
ClearedMicroselectron V3, Model 106.990
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nucletron Corporation · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Aug 17, 2006 as substantially equivalent to K041933 (Nucletron Corp., 2004) after a 94-day review. Its family tree reaches back 3 generations to 1986. 7 later devices descend from it.
- Decided
- Aug 17, 2006
- Review
- 94 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K864210 (1986). 4 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 2 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 1 generation backK041933 Microselectron PDRNucletron Corp. · 2004
- This deviceK061354 Microselectron V3, Model 106.990Nucletron Corporation · 2006
- Descendant · cites it directly · 4 of its ownK120993 Gammamedplus IX Brachytherapy Afterloader, Gammamedplus 3/24 IX…Varian Medical Systems, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK181903 BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide…Varian Medical Systems, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK191580 BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment…Varian Medical Systems, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK092804 Microselectron HDR V2, Model 105.999Nucletron Corp. · 2009
- Descendant · 4 generations on · 0 of its ownK221797 BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide…Varian Medical Systems, Inc. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K120993Gammamedplus IX Brachytherapy Afterloader, Gammamedplus 3/24 IX Brachytherapy AfterloaderVarian Medical Systems, Inc. · 2012 · cites it directly4descendants
- K181903BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length…Varian Medical Systems, Inc. · 2018 · 2 generations on2descendants
- K191580BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment DeviceVarian Medical Systems, Inc. · 2019 · 3 generations on1descendant
- K092804Microselectron HDR V2, Model 105.999Nucletron Corp. · 2009 · cites it directly1descendant
- K221797BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length…Varian Medical Systems, Inc. · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −2 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −1 | K041933 | Microselectron PDR | Nucletron Corp. | 2004 | — |
| 0 (this device) | K061354 | Microselectron V3, Model 106.990 | Nucletron Corporation | 2006 | — |
| +1 | K120993 | Gammamedplus IX Brachytherapy Afterloader, Gammamedplus 3/24 IX Brachytherapy… | Varian Medical Systems, Inc. | 2012 | — |
| +2 | K181903 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes… | Varian Medical Systems, Inc. | 2018 | — |
| +3 | K191580 | BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device | Varian Medical Systems, Inc. | 2019 | — |
| +1 | K092804 | Microselectron HDR V2, Model 105.999 | Nucletron Corp. | 2009 | — |
| +4 | K221797 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and… | Varian Medical Systems, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K041933 | Microselectron PDRSummary page 1…is substantially equivalent to the legally marketed predicate device cited in the table below: Nucletron BV MicroSelectron PDR K041933 Description: The MicroSelectron V3 delivers a radiation dose distribution conforming to treatment data, which is either, manual… | 2004 |
| † | K902533 | Pulsed Selectron | 1990 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K120993 (Varian Medical Systems, Inc., 2012) has gone furthest, with 4 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 | — |
What is it indicated for?
The MicroSelectron V3 is intended to enable an operator to apply, by remote control, a radionuclide source into the body (including Interstitial, Intracavitary, Intraluminal, Bronchial, Endovascular and Intra-operative) or to the surface of the body for radiation therapy.
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/K061354 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061354: Microselectron V3, Model 106.990.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061354
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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