510(k) Report

510(k) · Cleared

Cleared

Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR Applicator Set, Fletcher Williamson Applicator SE

K983341510(k) TraditionalCleared Apr 15, 1999204-day reviewClass II21 CFR 892.5700

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nucletron Corp. · JAQ System, Applicator, Radionuclide, Remote-Controlled

Cleared on Apr 15, 1999 as substantially equivalent to K953946 (Nucletron-Oldelft Corp., 1996) after a 204-day review. Its family tree reaches back 2 generations to 1986. 42 later devices descend from it.

Decided
Apr 15, 1999
Review
204 days
Class
Class II
Product code
JAQ
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K864210 (1986). 3 ancestors in all. 42 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1993: 1 other ancestor2004: 2 descendants cleared2002: 1 descendant cleared2014: 2 descendants cleared2008: 6 descendants cleared2009: 5 descendants cleared2012: 1 descendant cleared2005: 2 descendants cleared2003: 1 descendant cleared2020: 1 descendant cleared2017: 2 descendants cleared2018: 2 descendants cleared2007: 1 descendant cleared2010: 2 descendants cleared2006: 1 descendant cleared2025: 2 descendants cleared2016: 3 descendants cleared2013: 3 descendants cleared2019: 3 descendants cleared2022: 1 descendant cleared2024: 1 descendant clearedK864210 · Microselectron-HDR (High Dose Rate) · Nucletron-Oldelft Corp. · 1986K953946 · Microselectron-HDR Version 2 · Nucletron-Oldelft Corp. · 19961990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 9 descendants3 generations forward: 14 descendants4 generations forward: 6 descendants5 generations forward: 3 descendants6 generations forward: 5 descendants K953946 · Microselectron-HDR Version 2 · Nucletron-Oldelft Corp. · 1996K864210 · Microselectron-HDR (High Dose Rate) · Nucletron-Oldelft Corp. · 19860+5
  1. Root · 2 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
  2. 1 generation backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
  3. This deviceK983341 Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal…Nucletron Corp. · 1999
  4. Descendant · cites it directly · 34 of its ownK011690 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2002
  5. Descendant · 2 generations on · 33 of its ownK030558 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2003
  6. Descendant · 2 generations on · 17 of its ownK041929 Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2004
  7. Descendant · 3 generations on · 14 of its ownK071229 Senorad Multi-Lumen Balloon Source Applicator for BranchytherapySenorx, Inc. · 2007
  8. Descendant · 3 generations on · 11 of its ownK081079 Contura MLB Source Applicator for BrachytherapySenorx, Inc. · 2008

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12004: 22005: 22006: 12007: 12008: 62009: 52010: 22012: 12013: 32014: 22016: 32017: 22018: 22019: 32020: 12022: 12024: 12025: 2
2002high 6 (2008) · low 0 (2011)2026

Most influential descendants

Showing 5 of 42 · See all
  • K011690Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc. · 2002 · cites it directly34descendants
  • K030558Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc. · 2003 · 2 generations on33descendants
  • K041929Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories…Proxima Therapeutics, Inc. · 2004 · 2 generations on17descendants
  • K071229Senorad Multi-Lumen Balloon Source Applicator for BranchytherapySenorx, Inc. · 2007 · 3 generations on14descendants
  • K081079Contura MLB Source Applicator for BrachytherapySenorx, Inc. · 2008 · 3 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K864210Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp.1986—
−1K953946Microselectron-HDR Version 2Nucletron-Oldelft Corp.1996—
0 (this device)K983341Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR…Nucletron Corp.1999—
+1K011690Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader…Proxima Therapeutics, Inc.2002—
+2K030558Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader…Proxima Therapeutics, Inc.2003—
+2K041929Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader…Proxima Therapeutics, Inc.2004—
+3K071229Senorad Multi-Lumen Balloon Source Applicator for BranchytherapySenorx, Inc.2007—
+3K081079Contura MLB Source Applicator for BrachytherapySenorx, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200420
200520
200610
200710
200860
200950
201020
201210
201330
201420
201630
201720
201820
201930
202010
202210
202410
202520
FIG. 1 — Lineage of K983341, 1986–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241853 Titanium Fletcher-Style Applicator Set Defined…score 14.9 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K953946Microselectron-HDR Version 2
Summary page 1
…evice are substantially equivalent to the legally marketed predicate devices cited in the table below: Manufacturer Device 510(k) # Nucletron BV Standard Applicator Set K953946 Nucletron BV Ring Applicator Set K953946 Nucletron BV Vaginal Applicator Set K953946 Nucletron BV Standard Shielded Applicator Se…
Nucletron-Oldelft Corp.1996—

Also cleared against K953946: 27 other devices →

What descends from it? (42)

See all 42

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K011690Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc.200234
K032067Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc.20049
K091154Utrecht Interstitial Fletcher CT/MR Applicator Set, Model 110.270, Interstitial Ring…Nucletron Corporation20094
K132889Fletcher CT/MR Shielded Applicator Set (6 MM) Fletcher CT/MR Shielded Applicator Set (4…Nucletron B.V.20140
K082530Applicators for Afterloading BrachytherapyIsodose Control B.V.20080

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.
  • Of its descendants, K011690 (Proxima Therapeutics, Inc., 2002) has gone furthest, with 34 descendants of its own.
  • 27 other devices also cite its predicate K953946.

How does its category compare?

All JAQ devices

JAQ System, Applicator, Radionuclide, Remote-Controlled: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAQ

6in 2025

2007: 112008: 102009: 102010: 22011: 22012: 72013: 62014: 72015: 112016: 62017: 72018: 72019: 22020: 42022: 12023: 22024: 102025: 62026 (partial year): 2
2007high 11 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAQ

91in 2025

2007: 48 days median2008: 34 days median2009: 27 days median2012: 89 days median2013: 100 days median2014: 116 days median2015: 183 days median2016: 154 days median2017: 229 days median2018: 252 days median2020: 62 days median2024: 126 days median2025: 91 days median
2007high 252 (2018) · low 27 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JAQ

1in 2019

2008: 52009: 12010: 22011: 132012: 52013: 12019: 12026 (partial year): 3
2007high 13 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAQ

3in 2025

2007: 132008: 322009: 352010: 362011: 422012: 342013: 432014: 182015: 72016: 32017: 52018: 22019: 82020: 82021: 52022: 52023: 32024: 12025: 3
2007high 43 (2013) · low 1 (2024)2025

MAUDE reports naming product code JAQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071148013
20081034532
20091027135
20102—236
20112—1342
2012789534
20136100143
20147116018
20151118307
2016615403
2017722905
2018725202
20192—18
202046208
20210—05
20221—05
20232—03
20241012601
202569103
20262—3—

What is it indicated for?

Nucletron Intracavitary Applicator Sets: Vaginal CT/MR, Standard CT/MR, Ring CT/MR and Fletcher-Williamson are intended for use with the Nucletron remote afterloading equipment, mHDR, mHDR-Classic and mPOR, for intracavitary brachytherapy. The applicators provide a means of delivering the prescribed radiation dose to the treatment area. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K953946

27 other devices cite the same predicate.

  • K161688Advanced Gynecological ApplicatorNucletron B.V. · 20171 recall
  • K151272Henschke Titanium Applicator SetNucletron B.V. · 2015
  • K142986SagiNovaEckert & Ziegler Bebig GmbH · 2015
  • K140803Luneray;Catheter 6F 50CM, Needle 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MMNucletron B.V. · 2014
  • K111973Vaginal CT / MR Multi Channel Applicator SetNucletron · 2011
  • K092822Capri ApplicatorVivaray, Inc. · 2009

More from Nucletron Corp.

27 FDA decisions under this applicant name. See the company

  • K092804Microselectron HDR V2, Model 105.999Nucletron Corp. · 2009
  • K091598Lumencath Applicator Set, Models 189. 795, 189.796, 189.797, 189.798, Lumencath CathetersNucletron Corp. · 2009
  • K072445Integrated Brachytherapy Unit - DigitalNucletron Corp. · 2007
  • K041715Intracavitary Mould Applicator Set, Model 189.001Nucletron Corp. · 2005
  • K041933Microselectron PDRNucletron Corp. · 2004

Recent decisions in JAQ

The JAQ category page

  • K262383LumenCare AzureNucletron B.V. · 2026
  • K252717MAASTRO Rectal Applicator SetVarian Medical Systems · 2026
  • K251037Rectal ApplicatorNucletron B.V. · 2025
  • K252884Guided Aarhus Applicator SetVarian Medical Systems · 2025
  • K250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc. · 2025

https://510kreport.com/device/K983341 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983341: Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR Applicator Set, Fletcher Williamson Applicator SE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983341

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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