510(k) · Cleared
Recalled · Class II · 2012Gammamed Plus High Dose Rate Remote Afterloading System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gammamed USA · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Oct 29, 1998 as substantially equivalent to K912555 (Rts Technology, Inc., 1991) after a 30-day review. Its family tree reaches back 1 generation to 1991. 55 later devices descend from it. It has been recalled 17 times.
- Decided
- Oct 29, 1998
- Review
- 30 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- 17
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912555 (1991). 55 later devices descend from it, 13 citing it directly.
- Root · 1 generation backK912555 Gammamed 12IT High Dose Rate Remote AfterloaderRts Technology, Inc. · 1991 · Recalled
- This deviceK983436 Gammamed Plus High Dose Rate Remote Afterloading SystemGammamed USA · 1998
- Descendant · cites it directly · 29 of its ownK033371 Varian Intracavitary Brachytherapy ApplicatorsVarian Medical Systems · 2003 · Recalled
- Descendant · 2 generations on · 13 of its ownK070659 Biolucent Applicator KitBiolucent, Inc. · 2007
- Descendant · 3 generations on · 12 of its ownK080565 Modification to: Savi Applicator KitCianna Medical, Inc. · 2008
- Descendant · 2 generations on · 11 of its ownK081677 Savi Applicator KitCianna Medical, Inc. · 2008
- Descendant · 3 generations on · 9 of its ownK091378 Mammosite II Radiation Therapy SystemHologic, Inc. · 2009
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K033371Varian Intracavitary Brachytherapy ApplicatorsVarian Medical Systems · 2003 · cites it directly29descendants
- K070659Biolucent Applicator KitBiolucent, Inc. · 2007 · 2 generations on13descendants
- K080565Modification to: Savi Applicator KitCianna Medical, Inc. · 2008 · 3 generations on12descendants
- K081677Savi Applicator KitCianna Medical, Inc. · 2008 · 2 generations on11descendants
- K091378Mammosite II Radiation Therapy SystemHologic, Inc. · 2009 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912555 | Gammamed 12IT High Dose Rate Remote Afterloader | Rts Technology, Inc. | 1991 | 2 |
| 0 (this device) | K983436 | Gammamed Plus High Dose Rate Remote Afterloading System | Gammamed USA | 1998 | — |
| +1 | K033371 | Varian Intracavitary Brachytherapy Applicators | Varian Medical Systems | 2003 | 2 |
| +2 | K070659 | Biolucent Applicator Kit | Biolucent, Inc. | 2007 | — |
| +3 | K080565 | Modification to: Savi Applicator Kit | Cianna Medical, Inc. | 2008 | — |
| +2 | K081677 | Savi Applicator Kit | Cianna Medical, Inc. | 2008 | — |
| +3 | K091378 | Mammosite II Radiation Therapy System | Hologic, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 6 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K912555 | Gammamed 12IT High Dose Rate Remote AfterloaderSummary page 1…e Rate Remote Afterloading System Proprietary Name: GammaMed Plus High Dose Rate Remote Afterloading System 4) () Legally Marketed Predicate Device: =~ GammaMed 12it (K912555/A dated 17 July 1991) Substantial equivalence determined through premarket notification process Description of GammaMed Plus: T… | 1991 |
What descends from it? (55)
See all 5513 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033371 | Varian Intracavitary Brachytherapy Applicators | 2003 | 29 |
| K031524 | Gammamed Plus 3/24 HDR Remote Afterloader | 2003 | 7 |
| K071381 | Gammamedplus IX Series HDR Afterloader | 2007 | 5 |
| K162533 | Kelowna GYN and Crook Prostate Templates | 2017 | 1 |
| K162615 | Mould Applicator Set | 2017 | 1 |
| K160045 | Heyman Packing Applicator Set | 2016 | 1 |
| K151022 | Intraluminal Applicator Set | 2015 | 1 |
| K123815 | Surface Applicator Set with Leipzig-Style Cone | 2013 | 1 |
| K082653 | Centering Intraluminal Applicator | 2008 | 1 |
| K063815 | Varian Esophagus Bougie Applicator | 2007 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 28, 2012 | Class II | Z-0607-2013 | Device Design | The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve. |
| Jul 13, 2011 | Not classified | Z-2998-2011 | Device Design | Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. |
| Jul 13, 2011 | Not classified | Z-3000-2011 | Device Design | Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. |
| Jul 13, 2011 | Not classified | Z-2995-2011 | Device Design | Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. |
| Jul 13, 2011 | Not classified | Z-2992-2011 | Device Design | Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal. |
| Jul 13, 2011 | Not classified | Z-2999-2011 | Device Design | Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. |
| Jul 13, 2011 | Not classified | Z-3013-2011 | Process control | Certain GammaMed Flexible applicator probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave. |
| Jul 13, 2011 | Not classified | Z-2993-2011 | Device Design | Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal. |
| Jul 13, 2011 | Not classified | Z-2991-2011 | Device Design | Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal. |
| Jul 13, 2011 | Not classified | Z-2996-2011 | Device Design | Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. |
| Jul 13, 2011 | Not classified | Z-2997-2011 | Device Design | Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. |
| Sep 30, 2008 | Not classified | Z-0326-2012 | Nonconforming Material/Component | Plastic needle tip could possibly crack or separate. |
| Sep 30, 2008 | Not classified | Z-0328-2012 | Nonconforming Material/Component | Plastic needle tip could possibly crack or separate. |
| Sep 30, 2008 | Not classified | Z-0327-2012 | Nonconforming Material/Component | Plastic needle tip could possibly crack or separate. |
| Aug 5, 2008 | Not classified | Z-0295-2012 | Process control | GammaMed Flexible Applicator Probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave. |
| May 1, 2006 | Not classified | Z-1268-06 | 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… |
| Apr 14, 2005 | Not classified | Z-0921-05 | Other | A defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury. |
The 5 latest of 17 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K033371 (Varian Medical Systems, 2003) has gone furthest, with 29 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 intended use of the GammaMed Plus transportable high-dose-rate remotely controlled afterloading brachytherapy device is for the treatment of cancer by intracavitary, interstitial, intralumenal and intraoperative irradiation.
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/K983436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983436: Gammamed Plus High Dose Rate Remote Afterloading System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983436
Report an extraction error
Are you the manufacturer?
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