510(k) · Cleared
ClearedGammamedplus IX Series HDR Afterloader
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Jul 18, 2007 as substantially equivalent to K983436 (Gammamed USA, 1998) and 1 other predicate after a 62-day review. Its family tree reaches back 3 generations to 1991. 5 later devices descend from it.
- Decided
- Jul 18, 2007
- Review
- 62 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K912555 (1991). 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK912555 Gammamed 12IT High Dose Rate Remote AfterloaderRts Technology, Inc. · 1991 · Recalled
- 2 generations backK983436 Gammamed Plus High Dose Rate Remote Afterloading SystemGammamed USA · 1998 · Recalled
- 1 generation backK031524 Gammamed Plus 3/24 HDR Remote AfterloaderVarian Medical Systems, Inc. · 2003 · Recalled
- This deviceK071381 Gammamedplus IX Series HDR AfterloaderVarian Medical Systems · 2007
- 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 · 4 generations on · 0 of its ownK221797 BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide…Varian Medical Systems, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK142986 SagiNovaEckert & Ziegler Bebig GmbH · 2015
Most influential descendants
Showing 5 of 5 · 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
- K221797BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length…Varian Medical Systems, Inc. · 2022 · 4 generations on0descendants
- K142986SagiNovaEckert & Ziegler Bebig GmbH · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912555 | Gammamed 12IT High Dose Rate Remote Afterloader | Rts Technology, Inc. | 1991 | 2 |
| −2 | K983436 | Gammamed Plus High Dose Rate Remote Afterloading System | Gammamed USA | 1998 | 17 |
| −1 | K031524 | Gammamed Plus 3/24 HDR Remote Afterloader | Varian Medical Systems, Inc. | 2003 | 1 |
| 0 (this device) | K071381 | Gammamedplus IX Series HDR Afterloader | Varian Medical Systems | 2007 | — |
| +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 | — |
| +4 | K221797 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and… | Varian Medical Systems, Inc. | 2022 | — |
| +2 | K142986 | SagiNova | Eckert & Ziegler Bebig GmbH | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K983436 | Gammamed Plus High Dose Rate Remote Afterloading SystemSummary page 1…Class II Product Code: JAQ 3. Predicate Devices to claim substantial equivalence: a. GanmmaMedplus (K983436) b. GammaMedplus 3/24 (K031524) 4. Description of the Device: The GammaMedplus iX Series High Dose Rate After… | 1998 |
| * | K031524 | Gammamed Plus 3/24 HDR Remote AfterloaderSummary page 1…Product Code: JAQ 3. Predicate Devices to claim substantial equivalence: a. GanmmaMedplus (K983436) b. GammaMedplus 3/24 (K031524) 4. Description of the Device: The GammaMedplus iX Series High Dose Rate Afterloader system is a computer controlled… | 2003 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120993 | Gammamedplus IX Brachytherapy Afterloader, Gammamedplus 3/24 IX Brachytherapy Afterloader | 2012 | 4 |
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 16 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K120993 (Varian Medical Systems, Inc., 2012) has gone furthest, with 4 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. 2007, this device’s year, is highlighted.
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?
Both the GammaMedplus iX and GammaMedplus 3/24 iX are indicated, in the treatment benign and malignant disease, for both curative and palliative intent, in the delivery of both controlled high dose rate brachytherapy of remote for conditions anywhere in the body when brachytherapy treatment is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071381: Gammamedplus IX Series HDR Afterloader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071381
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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