510(k) · Cleared
Recalled · 2006Gammamed Plus 3/24 HDR Remote Afterloader
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Nov 26, 2003 as substantially equivalent to K983436 (Gammamed USA, 1998) after a 195-day review. Its family tree reaches back 2 generations to 1991. 7 later devices descend from it. It has been recalled once.
- Decided
- Nov 26, 2003
- Review
- 195 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K912555 (1991). 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK912555 Gammamed 12IT High Dose Rate Remote AfterloaderRts Technology, Inc. · 1991 · Recalled
- 1 generation backK983436 Gammamed Plus High Dose Rate Remote Afterloading SystemGammamed USA · 1998 · Recalled
- This deviceK031524 Gammamed Plus 3/24 HDR Remote AfterloaderVarian Medical Systems, Inc. · 2003
- Descendant · cites it directly · 5 of its ownK071381 Gammamedplus IX Series HDR AfterloaderVarian Medical Systems · 2007
- Descendant · 2 generations on · 4 of its ownK120993 Gammamedplus IX Brachytherapy Afterloader, Gammamedplus 3/24 IX…Varian Medical Systems, Inc. · 2012
- Descendant · 3 generations on · 2 of its ownK181903 BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide…Varian Medical Systems, Inc. · 2018
- Descendant · 4 generations on · 1 of its ownK191580 BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment…Varian Medical Systems, Inc. · 2019
- Descendant · 5 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- K071381Gammamedplus IX Series HDR AfterloaderVarian Medical Systems · 2007 · cites it directly5descendants
- K120993Gammamedplus IX Brachytherapy Afterloader, Gammamedplus 3/24 IX Brachytherapy AfterloaderVarian Medical Systems, Inc. · 2012 · 2 generations on4descendants
- K181903BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length…Varian Medical Systems, Inc. · 2018 · 3 generations on2descendants
- K191580BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment DeviceVarian Medical Systems, Inc. · 2019 · 4 generations on1descendant
- K221797BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length…Varian Medical Systems, Inc. · 2022 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912555 | Gammamed 12IT High Dose Rate Remote Afterloader | Rts Technology, Inc. | 1991 | 2 |
| −1 | K983436 | Gammamed Plus High Dose Rate Remote Afterloading System | Gammamed USA | 1998 | 17 |
| 0 (this device) | K031524 | Gammamed Plus 3/24 HDR Remote Afterloader | Varian Medical Systems, Inc. | 2003 | — |
| +1 | K071381 | Gammamedplus IX Series HDR Afterloader | Varian Medical Systems | 2007 | — |
| +2 | K120993 | Gammamedplus IX Brachytherapy Afterloader, Gammamedplus 3/24 IX Brachytherapy… | Varian Medical Systems, Inc. | 2012 | — |
| +3 | K181903 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes… | Varian Medical Systems, Inc. | 2018 | — |
| +4 | K191580 | BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device | Varian Medical Systems, Inc. | 2019 | — |
| +5 | K221797 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and… | Varian Medical Systems, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 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 |
|---|---|---|---|
| * | K983436 | Gammamed Plus High Dose Rate Remote Afterloading SystemSummary page 1…R Remote afterloader Proprietary Name: GammaMed plus 3/24 HDR Remote afterloader 3. Equivalent Device: GammaMed plus HDR Remote Afterloader, K983436 4. Device Description: The GammaMedplus3/24 is a remote afterloading system used to deliver a radioactive source for use… | 1998 |
What descends from it? (7)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 1, 2006 | Not classified | Z-1269-06 | Other | Medical device software for brachytherapy may cause erroneous data to be recorded and affect patient radiation treatments. Erroneous data may be listed on the treatment history report, and the default step size may lead to a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K071381 (Varian Medical Systems, 2007) has gone furthest, with 5 descendants of its own.
- 12 other devices also cite its predicate K983436.
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 GammaMedphs 3/24 is a remotely controlled afterloading brachytherapy device used to apply a radionuclide source into the body or to the surface of the body for radiation therapy. The system is designed to provide a predetermined dose of radiation to tissue and organs by means of manipulating a radioactive source from a shielded position within in the device into a catheter, applicator, or needle, which has been placed within or on a patient. The remote afterloading device must be contained in a shielded facility during extension of the radioactive source. The GammaMedplus 3/24 may optionally be configured as a transportable device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031524: Gammamed Plus 3/24 HDR Remote Afterloader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031524
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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